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
1297–1320 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL 2010
K982949 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Dade Behring, Inc.
Immunology · 18d
Cleared Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209 · MVM
The Binding Site, Ltd.
Immunology · 203d
Cleared Oct 22, 1998
UNICAP GLIADIN IGA ASSAY
K982533 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
UNICAP GLIADIN IGG ASSAY
K982701 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · DBF
Bayer Corp.
Immunology · 79d
Cleared Oct 21, 1998
TFR
K981208 · JNM
Ramco Laboratories, Inc.
Immunology · 202d
Cleared Oct 16, 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · JZG
Boehringer Mannheim Corp.
Immunology · 234d
Cleared Oct 16, 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES...
K982866 · JZO
Nichols Institute Diagnostics
Immunology · 63d
Cleared Oct 15, 1998
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · MOI
Chiron Diagnostics Corp.
Immunology · 76d
Cleared Oct 15, 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · MSV
Shield Diagnostics, Ltd.
Immunology · 62d
Cleared Oct 15, 1998
IMMULITE 2000 OM-MA MODEL L2KOP2
K983391 · LTK
Diagnostic Products Corp.
Immunology · 20d
Cleared Oct 13, 1998
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS...
K981634 · LTJ
Biocircuits Corp.
Immunology · 158d
Cleared Oct 08, 1998
AIA-PACK TPOAB ASSAY
K981521 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
AIA-PACK TGAB ASSAY
K981522 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 07, 1998
HYDRAGEL 6 CSF KIT
K981048 · CFF
Morax
Immunology · 201d
Cleared Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
K982603 · LLL
Inova Diagnostics, Inc.
Immunology · 72d
Cleared Sep 30, 1998
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG...
K973203 · DAK
Sangstat Medical Corp.
Immunology · 400d
Cleared Sep 29, 1998
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983130 · JJY
Kamiya Biomedical Co.
Immunology · 21d
Cleared Sep 29, 1998
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983241 · JJY
Kamiya Biomedical Co.
Immunology · 14d
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382 · CFN
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Sep 24, 1998
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205,...
K981985 · DHX
Beckman Coulter, Inc.
Immunology · 111d