Data / Medical devices / United States / Bio-Rad Laboratories Inc.
Bio-Rad Laboratories Inc.: FDA-registered device maker in Irvine, CA, United States, 108 510(k) clearances
Bio-Rad Laboratories Inc. is registered with the FDA (registration 3010127294) in Irvine, CA, United States. It lists 19 device types. The FDA files 108 510(k) clearances under its listings, the newest dated January 10, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010127294
- Address
- 9 Holland, Irvine, CA, United States, 92618
- Owner or operator
- Bio-Rad Laboratories, Inc. (9929003)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 17, 2008
- Registered through
- 2026
- Brand names listed
- Amplichek II, Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2, InteliQ Assayed Muliqual Control, InteliQ Cardiac Advance Control, InteliQ Cardiac Markers Plus Control LT, InteliQ Diabetes Control (12008309, 12008310, 12008311, 12008312), InteliQ Ethanol/Ammonia Control, InteliQ Homocysteine Control and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 108.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2017 | K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 28, 2016 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak | PMN | Unknown | Bio-Rad Laboratories | accessdata.fda.gov |
| December 11, 2015 | K150300 | Liquichek Cardiac Markers Plus Control LT | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 13, 2015 | K143379 | Liquichek Maternal Serum II Control | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| June 23, 2014 | K141073 | LIQUICHEK TUMOR MARKER CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 6, 2014 | K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| April 24, 2014 | K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| January 22, 2014 | K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| October 25, 2013 | K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 6, 2013 | K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| April 12, 2013 | K130761 | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 1, 2013 | K130162 | LIQUID ASSAYED MULTIQUAL PREMIUM | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| January 31, 2013 | K123775 | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| January 9, 2013 | K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | JJX | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| December 27, 2012 | K123663 | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| November 20, 2012 | K123198 | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| October 17, 2012 | K122838 | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| July 11, 2012 | K121794 | LIQUICHEK URINE CHEMISTRY CONTROL | JJY | Substantially Equivalent | Bio-Rad, Diagnostics Grp. | accessdata.fda.gov |
| May 18, 2012 | K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | DIF | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 27, 2012 | K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | DIF | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| September 14, 2010 | K100727 | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK | JJY | Substantially Equivalent | Bio-Rad, Diagnostics Grp. | accessdata.fda.gov |
| March 12, 2010 | K093577 | LIQUICHEK OPIATE CONTROL | DIF | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| January 29, 2010 | K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| October 28, 2009 | K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| September 8, 2008 | K082036 | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| December 11, 2007 | K072835 | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK | JJY | Substantially Equivalent | Bio-Rad, Diagnostics Grp. | accessdata.fda.gov |
| December 11, 2007 | K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | DIF | Substantially Equivalent | Bio-Rad, Diagnostics Grp. | accessdata.fda.gov |
| July 3, 2007 | K071675 | LIQUICHEK TUMOR MARKER CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| April 25, 2007 | K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | JJW | Substantially Equivalent | Bio-Rad, Diagnostics Grp. | accessdata.fda.gov |
| April 2, 2007 | K070546 | LYPHOCHEK DIABETES CONTROL | GGM | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| November 9, 2005 | K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | GGM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 9, 2005 | K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 29, 2005 | K050682 | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | DIF | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| April 27, 2005 | K050537 | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| March 24, 2005 | K050536 | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 7, 2005 | K043208 | LIQUID ASSAYED MULTIQUAL CONTROL | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| December 7, 2004 | K043108 | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| November 24, 2004 | K042865 | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 5, 2004 | K042815 | QUEST TUMOR MARKER CONTROL, MODEL 955 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 2, 2004 | K042837 | LIQUICHEK ELEVATED CRP CONTROL | JJX | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 2, 2004 | K042446 | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | JJW | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| October 14, 2004 | K042336 | METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK | JPK | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042094 | R&D CBC-XE HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040822 | LIQUICHEK TORCH PLUS IGM CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| March 10, 2004 | K040277 | LIQUICHEK CARDIAC MARKER CONTROL LT | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| March 4, 2004 | K040273 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| February 27, 2004 | K040275 | LYPHOCHEK HEMOSTASIS CONTROL | GGN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| February 3, 2004 | K033924 | LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) | DIF | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 12, 2003 | K033404 | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| December 2, 2003 | K033387 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 8, 2003 | K032017 | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 | GGN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 17, 2003 | K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 15, 2003 | K024230 | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 15, 2003 | K024227 | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 15, 2003 | K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 15, 2003 | K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 15, 2003 | K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | DHN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| September 17, 2002 | K022991 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 15, 2002 | K022529 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| July 16, 2002 | K022041 | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 29, 2002 | K021411 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 22, 2002 | K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | DIE | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 12, 2002 | K020817 | LIQUICHEK URINE CHEMISTRY CONTROL | JJY | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| September 18, 2001 | K012722 | LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 | GGN | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| September 12, 2001 | K012741 | LIQUICHEK TDM CONTROL | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 29, 2001 | K012513 | LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| June 26, 2001 | K011579 | LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| May 11, 2001 | K010470 | R & D 4K RETIC | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| April 3, 2001 | K010461 | ADVIA RETIC PLUS | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| January 12, 2001 | K003874 | CBC-4K HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 30, 2000 | K003239 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 29, 2000 | K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | GGM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 7, 2000 | K003208 | R & D 3K RETIC | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| September 25, 2000 | K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 30, 2000 | K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 30, 2000 | K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 21, 2000 | K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 7, 2000 | K002196 | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| May 25, 2000 | K001373 | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 9, 1999 | K992741 | LYPHOCHEK ANEMIA CONTROL, MODEL 500 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 16, 1999 | K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | DIE | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 7, 1999 | K990888 | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| February 17, 1999 | K983032 | CBC-5D HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| February 2, 1999 | K984594 | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| December 14, 1998 | K984225 | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| December 3, 1998 | K984071 | LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 | JJX | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| May 12, 1998 | K981532 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| January 27, 1998 | K974613 | VIROTROL III | JJY | Substantially Equivalent | Blackhawk Biosystems, Inc. | accessdata.fda.gov |
| June 16, 1997 | K971952 | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| June 16, 1997 | K971405 | SPECIALITY URINE 1,2 | JJY | Substantially Equivalent | Chiron Diagnostics Corp. | accessdata.fda.gov |
| March 10, 1997 | K970666 | LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| June 4, 1996 | K960987 | LIQUICHEK RHEUMATOID FACTOR CONTROL | DHR | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| February 5, 1996 | K955153 | LYPHOCHEK BENZO/TCA CONTROL-SET B | DIF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 28, 1995 | K955024 | LIQUICHEK ETHANOL/AMMONIA CONTROL | JJY | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 1, 1995 | K954298 | VIROTROL IV | JJY | Substantially Equivalent | Blackhawk Biosystems, Inc. | accessdata.fda.gov |
| October 7, 1994 | K942295 | VIROTROL TORCH | JJY | Substantially Equivalent | Blackhawk Biosystems, Inc. | accessdata.fda.gov |
| June 10, 1991 | K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | JCM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 23, 1990 | K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | JJT | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 22, 1990 | K902389 | TRI-COUNT 16 | JCN | Substantially Equivalent | Hematronix, Inc. | accessdata.fda.gov |
| February 27, 1989 | K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
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Updated January 10, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.