Data / Medical devices / United States / Cliniqa Corporation
Cliniqa Corporation: FDA-registered device maker in San Marcos, CA, United States, 90 510(k) clearances
Cliniqa Corporation is registered with the FDA (registration 2085064) in San Marcos, CA, United States. It lists 54 device types. The FDA files 90 510(k) clearances under its listings, the newest dated May 31, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085064
- FEI number
- 1000135102
- Address
- 495 Enterprise Street, San Marcos, CA, United States, 92078
- Owner or operator
- CLINIQA CORPORATION (2083131)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 6, 2006
- Registered through
- 2026
- Brand names listed
- ALT (GPT) Reagent, AMMONIA REAGENT, AMYLASE REAGENT, APO A-1 Reagent, APO B Reagent, Alkaline Phosphatase Reagent, Amylase Reagent, Assayed Control Serum Level 1 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2013 | K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | GGN | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| May 18, 2012 | K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 23, 2012 | K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | JJY | Substantially Equivalent | Randox Laboratories Limited | accessdata.fda.gov |
| April 21, 2009 | K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 16, 2009 | K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | JJW | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| September 17, 2008 | K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| June 2, 2008 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| May 4, 2007 | K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 23, 2006 | K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| May 25, 2006 | K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| April 13, 2006 | K060570 | HEMOGLOBIN ALC CONTROL | JJX | Substantially Equivalent | Compass Bioscience | accessdata.fda.gov |
| March 21, 2006 | K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | JIT | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| November 18, 2005 | K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 26, 2005 | K043264 | LDL-EX SEIKEN ASSAY KIT | MRR | Substantially Equivalent | Denka Seiken Co., Ltd. | accessdata.fda.gov |
| October 29, 2004 | K041090 | HDL-EX SEIKEN ASSAY KIT | LBS | Substantially Equivalent | Denka Seiken Co., Ltd. | accessdata.fda.gov |
| August 16, 2004 | K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| June 25, 2004 | K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | CIC | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| May 17, 2004 | K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| March 29, 2004 | K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| March 5, 2004 | K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| February 23, 2004 | K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 30, 2004 | K033910 | OLYMPUS URINE CALIBRATOR | JIX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 21, 2003 | K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 10, 2003 | K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| August 25, 2003 | K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| August 6, 2003 | K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| August 6, 2003 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 23, 2003 | K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| June 16, 2003 | K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | JJY | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| March 26, 2003 | K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| March 21, 2003 | K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | JJT | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| March 13, 2003 | K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 28, 2003 | K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| January 21, 2003 | K030074 | LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | JIX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| December 6, 2002 | K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 17, 2002 | K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 2, 2002 | K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 2, 2002 | K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 2, 2002 | K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| September 17, 2002 | K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | MRR | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| September 17, 2002 | K022758 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| September 3, 2002 | K022767 | RAICHEM LIPID CALIBRATOR | JIX | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| August 27, 2002 | K022491 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| August 1, 2002 | K022232 | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| July 29, 2002 | K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | DCK | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| July 19, 2002 | K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | CJY | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| November 20, 2001 | K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 15, 2001 | K012668 | RAICHEM GLUCOSE UV REAGENT | CFR | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| October 15, 2001 | K012649 | RAICHEM BUN RATE REAGENT | CDQ | Substantially Equivalent | Hemagen Diagnostics, Inc. | accessdata.fda.gov |
| May 18, 2001 | K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 | JJY | Substantially Equivalent | International Enzymes, Inc. | accessdata.fda.gov |
| September 21, 1998 | K982767 | RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR | JIX | Substantially Equivalent | Raichem | accessdata.fda.gov |
| June 24, 1998 | K982056 | RAICHEM CO2 REAGENT | KHS | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| September 24, 1997 | K972853 | CHOLESTEROL RAPID LIQUID REAGENT | CHH | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| August 20, 1996 | K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | JJX | Substantially Equivalent | International Enzymes, Inc. | accessdata.fda.gov |
| April 24, 1996 | K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | JJY | Substantially Equivalent | Clinical Controls, Inc. | accessdata.fda.gov |
| April 24, 1996 | K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | JJY | Substantially Equivalent | Clinical Controls, Inc. | accessdata.fda.gov |
| September 15, 1995 | K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | DCF | Substantially Equivalent | International Enzymes, Inc. | accessdata.fda.gov |
| September 15, 1995 | K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | DCK | Substantially Equivalent | International Enzymes, Inc. | accessdata.fda.gov |
| October 13, 1992 | K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | CDN | Substantially Equivalent | King Diagnostics, Inc. | accessdata.fda.gov |
| September 9, 1992 | K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | JPZ | Substantially Equivalent | King Diagnostics, Inc. | accessdata.fda.gov |
| July 30, 1992 | K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | JJX | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| July 26, 1991 | K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | DKC | Substantially Equivalent | Cala Diagnostics | accessdata.fda.gov |
| December 20, 1990 | K905085 | RAICHEM GGT REAGENT | JQB | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| December 20, 1990 | K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | CGS | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 28, 1990 | K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT | DCN | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| August 29, 1988 | K882726 | RAICHEM(TM) BILIRUBIN STANDARD | JIS | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| January 21, 1988 | K874822 | RAICHEM(TM) MAGNESIUM REAGENT | JGJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 15, 1987 | K872080 | RAICHEM(TM) SPIA(TM) APO B REAGENTS | DFC | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 15, 1987 | K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS | MSJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| February 12, 1987 | K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) | JFY | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| February 12, 1987 | K864819 | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS | JIY | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| January 5, 1987 | K864706 | RAICHEM(TM) AMMONIA REAGENT | JIF | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| September 26, 1986 | K863620 | RAICHEM(TM) CHLORIDE REAGENT | CHJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 27, 1986 | K862168 | RAICHEM CHOLINESTERASE REAGENT | DIH | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| May 29, 1986 | K861718 | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 | JFJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| May 29, 1986 | K861269 | RAICHEM AMYLASE REAGENT | JFJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| December 13, 1985 | K854544 | RAICHEM CO2 REAGENT | KHS | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| January 3, 1985 | K844316 | RAICHEM PHOSPHORUS REAGENT | CEO | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| July 9, 1984 | K842029 | TRIGLYCERIDES-GPO REAGENT | CDT | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 7, 1984 | K841892 | RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT | CIG | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| April 18, 1984 | K840872 | RAICHEM CREATININE REAGENT | CGX | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| September 12, 1983 | K832463 | RAICHEM ALKALINE PHOSPHATASE REAGENT | CJE | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| June 16, 1983 | K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- | CFJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| March 21, 1983 | K830207 | RAICHEM HDL-CHOLESTEROL REAGENT | LBR | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| August 27, 1982 | K822312 | RAICHEM LDH-L REAGENT | CFJ | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| April 1, 1982 | K820644 | RAICHEM TM CREATINE KINASE REAGENT | CGS | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| March 15, 1982 | K820525 | RAICHEM GPT (ALT) REAGENT | CKA | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| February 18, 1982 | K820270 | RAICHEM GOT (AST) REAGENT | CIT | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| October 2, 1981 | K812641 | URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM | KNK | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| January 16, 1981 | K803287 | CHOLESTEROL REAGENT ENZYMATIC | CHH | Substantially Equivalent | Rai, Inc. | accessdata.fda.gov |
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Updated May 31, 2013. 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.