Data / Medical devices / United States / Fisher Diagnostics
Fisher Diagnostics: FDA-registered device maker in Middletown, VA, United States, 81 510(k) clearances
Fisher Diagnostics is registered with the FDA (registration 1181121) in Middletown, VA, United States. It lists 118 device types. The FDA files 81 510(k) clearances under its listings, the newest dated June 1, 2017. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1181121
- Address
- 8365 Valley Pike, Middletown, VA, United States, 22645
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 16, 1992
- Registered through
- 2026
- Brand names listed
- ,LOW, 1.3% SALINE CS-555, 100% Dehydrant, 125I T3 UPTAKE RADIOASSAY KIT, 60% Dehydrant, 70% Dehydrant, 80% Dehydrant, 95% Dehydrant 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 |
|---|---|---|---|---|---|---|
| June 1, 2017 | K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls | PRI | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| May 22, 2007 | K070064 | AMYLASE EPS REAGENT | JFJ | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| March 23, 2007 | K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | JFY | Substantially Equivalent | Thermo Electron Corp. | accessdata.fda.gov |
| September 22, 2006 | K062204 | ARCHITECT CORTISOL ASSAY | JFT | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| July 18, 2006 | K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | JZO | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| May 10, 2006 | K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | JZO | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| November 9, 2005 | K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | JIT | Substantially Equivalent | Reference Diagnostics, Inc. | accessdata.fda.gov |
| September 23, 2005 | K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM | JJY | Substantially Equivalent | Thermo-Electron Corp. | accessdata.fda.gov |
| January 24, 2005 | K042924 | ARCHITECT STAT MYO IMMUNOASSAY | DDR | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| November 3, 2004 | K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | JIT | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| August 12, 2004 | K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | MMI | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| July 21, 2004 | K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | JHX | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| November 18, 2003 | K032753 | GLUCOSE TOLERANCE BEVERAGE | MRV | Substantially Equivalent | Perk Scientific, Inc. | accessdata.fda.gov |
| December 9, 2002 | K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | GKP | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| July 25, 2002 | K022108 | THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 | JIX | Substantially Equivalent | Thermo Dma, Inc. | accessdata.fda.gov |
| February 15, 2002 | K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | JIX | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| December 21, 2001 | K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | JJY | Substantially Equivalent | Medical Analysis Systems, Inc. | accessdata.fda.gov |
| October 16, 2001 | K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | JIS | Substantially Equivalent | Thermo Dma, Inc. | accessdata.fda.gov |
| September 7, 2001 | K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | GGN | Substantially Equivalent | Fisher Diagnostics | accessdata.fda.gov |
| February 5, 2001 | K002642 | MINIQUANT D-DIMER, MODEL 1447 | DAP | Substantially Equivalent | Biopool Intl., Inc. | accessdata.fda.gov |
| January 17, 2001 | K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | NDW | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| May 2, 2000 | K000781 | DIRECT TIBC KIT | JMO | Substantially Equivalent | Reference Diagnostics, Inc. | accessdata.fda.gov |
| March 24, 2000 | K000679 | THROMBOSTRATE CONTROL PLASMAS | GGN | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| September 3, 1999 | K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | KQG | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| June 21, 1999 | K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | KQG | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| February 17, 1999 | K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| December 1, 1998 | K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | GGC | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| December 1, 1998 | K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | GGC | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| December 1, 1998 | K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | GIZ | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| March 10, 1998 | K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CFR | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| January 7, 1998 | K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | CKA | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| January 2, 1998 | K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | JIF | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| December 19, 1997 | K974290 | MICROPROTEIN STANDARD KIT | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| July 23, 1997 | K972333 | AMMONIA/IRON STANDARD KIT | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| May 27, 1997 | K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CDO | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| May 27, 1997 | K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | CDQ | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| August 5, 1996 | K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY | CDT | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| May 23, 1996 | K961114 | AST INCORPORATING DST | CIT | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| April 25, 1996 | K961123 | ALT INCORPORATING DST | CKA | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| April 5, 1996 | K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY | CDT | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| October 7, 1995 | K954074 | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL | JJY | Substantially Equivalent | Aalto Scientific, Ltd. | accessdata.fda.gov |
| February 14, 1995 | K940082 | THROMBOSCREEN THROMBOPLASTIN-DS | GJS | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| November 15, 1994 | K944462 | DMA IRON PROCEDURE | JIY | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| September 21, 1993 | K931786 | ACE CLINICAL CHEMISTRY SYSTEM | JJE | Substantially Equivalent | Schiapparelli Biosystems, Inc. | accessdata.fda.gov |
| June 7, 1993 | K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | JIS | Substantially Equivalent | Analytical Control Systems, Inc. | accessdata.fda.gov |
| March 29, 1993 | K925794 | TRACE MICROPROTEIN REAGENT | JGQ | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| February 18, 1993 | K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | JJX | Substantially Equivalent | Analytical Control Systems, Inc. | accessdata.fda.gov |
| October 16, 1992 | K920668 | MINUTEX D-DIMER LATEX TEST | GHH | Substantially Equivalent | Biopool AB | accessdata.fda.gov |
| August 12, 1992 | K922995 | LIPID CONTROLS | JJX | Substantially Equivalent | Creative Laboratory Products, Inc. | accessdata.fda.gov |
| March 11, 1992 | K920603 | TRACE MAGNESIUM - ARSENAZO REAGENT | JGJ | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| November 19, 1991 | K914731 | TRACE GAMMA GT-SS REAGENT | JQB | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| November 8, 1991 | K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | JIT | Substantially Equivalent | Creative Laboratory Products, Inc. | accessdata.fda.gov |
| January 23, 1991 | K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II | JJY | Substantially Equivalent | Creative Laboratory Products, Inc. | accessdata.fda.gov |
| September 13, 1990 | K903896 | CALCIUM ARSENAZO III REAGENT | CIC | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| May 16, 1989 | K891761 | GDS ENZYMATIC THEOPHYLLINE REAGENT | LCY | Substantially Equivalent | Gds Diagnostics | accessdata.fda.gov |
| April 21, 1989 | K891337 | THROMBOSCREEN APTT REAGENT | GFO | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| September 2, 1988 | K875285 | MULTI-CHEMISTRY LINEARITY STANDARD | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| June 24, 1988 | K882116 | TOTAL PROTEIN/ALBUMIN STANDARD | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| April 18, 1988 | K880798 | ACID PHOSPHATASE REAGENT | CKB | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| April 18, 1988 | K880795 | RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. | CJE | Substantially Equivalent | Trace America, Inc. | accessdata.fda.gov |
| August 21, 1987 | K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD | CIC | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| August 19, 1987 | K870372 | ALBUMIN REAGENT - BROMCRESOL GREEN METHOD | CIX | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| August 19, 1987 | K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD | CEK | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| August 5, 1987 | K872023 | AMYLASE TEST KIT | JFJ | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| October 16, 1986 | K863585 | CHLORIDE PROCEDURE | CHJ | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| October 3, 1986 | K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | JPZ | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| June 13, 1986 | K861654 | ALBUMIN PROCEDURE | CIX | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| June 5, 1986 | K861665 | CREATINE PHROSPHOKINASE (CK) PROCEDURE | CGS | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| May 29, 1986 | K861667 | ALKALINE PHOSPHATASE PROCEDURE | CJE | Substantially Equivalent | Data Medical Associates, Inc. | accessdata.fda.gov |
| April 24, 1986 | K860715 | ALP (ALKALINE PHOSPHATASE) REAGENT | CJE | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| April 21, 1986 | K860726 | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID | LFR | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| April 7, 1986 | K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | CFJ | Substantially Equivalent | Trace Scientific , Ltd. | accessdata.fda.gov |
| October 31, 1985 | K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | GHM | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| September 17, 1985 | K852512 | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT | GHH | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| February 3, 1984 | K834086 | CONTACT-K APTT REAGENT | GGN | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| July 18, 1983 | K831844 | DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | Gilford Diagnostics | accessdata.fda.gov |
| August 13, 1981 | K812110 | GILCHEM CALCIUM REAGENT | CIC | Substantially Equivalent | Gilford Diagnostics | accessdata.fda.gov |
| May 30, 1980 | K800826 | FIBRINOGEN SCREEN | KQJ | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| October 17, 1979 | K791725 | CHOLINESTERASE REAGENT | DIH | Substantially Equivalent | Gilford Diagnostics | accessdata.fda.gov |
| December 4, 1978 | K781880 | ASSAY KIT, THROMBO-SCREEN | GIS | Substantially Equivalent | Pacific Hemostasis | accessdata.fda.gov |
| December 4, 1978 | K781865 | IRON BINDING CAPICITY MODEL 0370 | JIY | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 6, 2025 | 96488 | Class II | Ongoing | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | accessdata.fda.gov |
| May 19, 2017 | 77340 | Class II | Terminated | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC,a part of Thermo Fish | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensi | accessdata.fda.gov |
| October 6, 2010 | 57107 | Not yet classified | Terminated | Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22 | An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples. | accessdata.fda.gov |
| September 3, 2004 | 30004 | Not yet classified | Terminated | Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations. | Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives. | accessdata.fda.gov |
| July 1, 2004 | 29573 | Not yet classified | Terminated | Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. | Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples. | accessdata.fda.gov |
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Updated March 31, 2025. 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.