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
1489–1512 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 16, 1997
ELECSYS CEA ASSAY
K964368 · JIT
Boehringer Mannheim Corp.
Immunology · 227d
Cleared Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · CZW
Beckman Instruments, Inc.
Immunology · 190d
Cleared Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · MID
Immco Diagnostics, Inc.
Immunology · 145d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · MID
Hemagen Diagnostics, Inc.
Immunology · 74d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · JIX
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF...
K971788 · DHR
Beckman Instruments, Inc.
Immunology · 20d
Cleared Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
K964986 · MST
Inova Diagnostics, Inc.
Immunology · 171d
Cleared Jun 02, 1997
ELECSYS FERRITIN
K971833 · JMG
Boehringer Mannheim Corp.
Immunology · 14d
Cleared May 30, 1997
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
K964341 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
K964985 · MST
Inova Diagnostics, Inc.
Immunology · 168d
Cleared May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767 · JZG
R&D Systems, Inc.
Immunology · 183d
Cleared May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
K964791 · JZG
Bayer Corp.
Immunology · 181d
Cleared May 27, 1997
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K970718 · JNM
R&D Systems, Inc.
Immunology · 90d
Cleared May 23, 1997
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
K963803 · MOI
Centocor, Inc.
Immunology · 242d
Cleared May 23, 1997
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
K971658 · DBL
Jay H. Geller
Immunology · 39d
Cleared May 21, 1997
HYCOR ALLERGEN DISC
K965094 · DHB
Hycor Biomedical, Inc.
Immunology · 153d
Cleared May 21, 1997
ANCA COMBI DIAGNOSTIC TEST KIT
K965133 · MOB
The Binding Site, Ltd.
Immunology · 149d
Cleared May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
K964781 · DDS
Beckman Instruments, Inc.
Immunology · 163d
Cleared Apr 30, 1997
AURA TEK FDP
K970353 · MMW
Perimmune, Inc.
Immunology · 90d
Cleared Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695 · DCF
Beckman Instruments, Inc.
Immunology · 158d
Cleared Apr 25, 1997
VENTANA ANTI-S100 PRIMARY ANTIBODY
K941514 · DEH
Ventana Medical Systems, Inc.
Immunology · 1123d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · DDB
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · DEM
Beckman Instruments, Inc.
Immunology · 149d