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
1489–1512 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · DHR
Boehringer Mannheim Corp.
Immunology · 64d
Cleared Jun 16, 1997
N-ASSAY TIA TRANSFERRIN TEST KIT
K964295 · DDG
Crestat Diagnostics, Inc.
Immunology · 230d
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