FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
1393–1416 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · MOI
Abbott Laboratories
Immunology · 371d