Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1393–1416 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505 · DBF
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Feb 17, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · DEB
Beckman Instruments, Inc.
Immunology · 74d
Cleared Feb 17, 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
K974701 · MOB
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 17, 1998
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
K974702 · MOB
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 09, 1998
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
K973692 · DCK
United Biotech, Inc.
Immunology · 136d
Cleared Feb 09, 1998
ALLERGAN IMMUNO CAP M4, M8, K70
K974350 · DHB
Pharmacia, Inc.
Immunology · 82d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
ALLERGEN IMMUNOCAP F256,F245,F207,F202
K974580 · DHB
Pharmacia & Upjohn Co.
Immunology · 63d
Cleared Jan 09, 1998
TINA-QUANT PREALBUMIN
K972638 · JZJ
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jan 09, 1998
TINA-QUANT HAPTOGLOBIN
K972639 · DAD
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jan 09, 1998
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640 · DEM
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · LTJ
Boehringer Mannheim Corp.
Immunology · 60d
Cleared Dec 12, 1997
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12,...
K971905 · DEH
Dako Corp.
Immunology · 203d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790 · MSV
Theratest Laboratories, Inc.
Immunology · 130d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882 · MSV
Theratest Laboratories, Inc.
Immunology · 52d
Cleared Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · MOI
Bayer Corp.
Immunology · 374d
Cleared Dec 01, 1997
MONOCOL/LEX-IM TEST
K972457 · KTN
Immunostics Inc.,
Immunology · 153d
Cleared Nov 25, 1997
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · DHR
Immunostics Inc.,
Immunology · 147d
Cleared Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · DCK
Beckman Instruments, Inc.
Immunology · 31d
Cleared Nov 21, 1997
ELECSYS AFP
K973351 · LOJ
Boehringer Mannheim Corp.
Immunology · 77d
Cleared Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · JZG
Beckman Instruments, Inc.
Immunology · 44d
Cleared Nov 13, 1997
VIRGO ANCA SCREEN KIT
K973822 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
PR 3 ANTIBODY KIT
K973823 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d