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
3673–3696 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 14, 1977
CLASP RIA KIT, HTSH
K770915 · JLW
E. R. Squibb & Sons, Inc.
Immunology · 26d
Cleared Jun 03, 1977
RABBIT COMPLEMENT
K770866 · DHL
Cedarlake Labs , Ltd.
Immunology · 23d
Cleared May 26, 1977
T3 UPTAKE REAGENT SET
K770845 · KHQ
The Dow Chemical Co.
Immunology · 17d
Cleared May 26, 1977
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
K770854 · CEP
Nichols Institute Diagnostics
Immunology · 17d
Cleared May 25, 1977
MICROBIO. PROD. FLUORESCENT ANTIBODY
K770801 · GMY
Pfizer Pharmaceuticals
Immunology · 23d
Cleared May 20, 1977
RIALYZE HPL (RIA)
K770659 · JMF
Miles Laboratories, Inc.
Immunology · 43d
Cleared May 20, 1977
T-4 RIA REAGENT SET
K770676 · CDX
G.D. Searle and Co.
Immunology · 39d
Cleared May 20, 1977
T-3 RIA REAGENT SET
K770677 · CDP
G.D. Searle and Co.
Immunology · 39d
Cleared May 20, 1977
RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
K770804 · GQG
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
MEASLES-FA LABELLED (8-441 RF)
K770805 · GOL
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELLED (8-321 RF)
K770806 · GQX
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
ADENOVIRUS-GROUP FA LABELLED (8-651 RF)
K770807 · GNY
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
RESP. SYNCYTIAL-FA LABELLED PRESERUM
K770808 · GQG
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
MEASLES-FA LABELED PRESERUM (8-441 RNF)
K770809 · GOL
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELED PRESERUM
K770810 · GQX
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
ADENOVIRUS GROUP-FA LABELLED PRESERUM
K770811 · GNY
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 03, 1977
LAS-R TM HUMAN COMPLEMENT C4 TEST
K770547 · DAK
Hyland Therapeutic Div., Travenol...
Immunology · 43d
Cleared Apr 28, 1977
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · CDX
Abbott Laboratories
Immunology · 48d
Cleared Apr 28, 1977
DASP TM ANTI-RABBIT
K770597 · DEW
Organon, Inc.
Immunology · 30d
Cleared Apr 28, 1977
FLUORESCEIN CONJUGATED ANTISERUM
K770668 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
RHODAMINE-CONJUGATED ANTISERUM
K770669 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
FLOR. CONJUG. HUMAN FAB FRAGMENT
K770670 · DFK
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
RIA KIT, T4 CLASP
K770726 · CDX
Squibb & Sons, Inc.
Immunology · 9d
Cleared Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
K770467
Hoffmann-La Roche, Inc.
Immunology · 48d