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
3649–3672 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 14, 1977
CRP-WELLCOTEST
K771139 · DCN
Burroughs Wellcome Co.
Immunology · 17d
Cleared Jul 14, 1977
RHODAMINE-CONJUGATED ANTISERUM
K771144 · DBY
Kent Laboratories, Inc.
Immunology · 17d
Cleared Jul 11, 1977
CENTRIA SEPARATION COLUMNS TYPE A
K771118 · CEM
Clinical Diagnostics, Inc.
Immunology · 20d
Cleared Jun 27, 1977
QUANTA-MATE VITAMIN B-12/FOLATE RA
K771047 · CDD
Bio-Rad
Immunology · 17d
Cleared Jun 27, 1977
PHADEBAS T3 U TEST
K771078 · KHQ
Pharmacia, Inc.
Immunology · 12d
Cleared Jun 24, 1977
EAGENT SYSTEM, CORTISOL, ARIA
K770731
Bd Becton Dickinson Vacutainer...
Immunology · 65d
Cleared Jun 24, 1977
REAGENT SYSTEM, THYROXINE, ARIA
K770733 · CDX
Bd Becton Dickinson Vacutainer...
Immunology · 65d
Cleared Jun 24, 1977
GOAT ANTISERUM IGG NEPHELOMETRIC
K770961 · DEW
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM IGA NEPHELOMETRIC
K770962 · CZP
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM IGM NEPHELOMHTRIC
K770963 · DFT
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
GOAT ANTISERUM COMPLEMENT C3 NEPHEL.
K770964 · DAK
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 24, 1977
ANA TEST
K771064 · DHN
Gull Laboratories, Inc.
Immunology · 11d
Cleared Jun 23, 1977
CENTRIA CORTISOL RIA
K771117 · CGR
Clinical Diagnostics, Inc.
Immunology · 2d
Cleared Jun 22, 1977
REAGENT SYSTEM, PROGESTERONE, ARIA
K770732 · JLS
Bd Becton Dickinson Vacutainer...
Immunology · 63d
Cleared Jun 22, 1977
REAGENT SET, T-4, CPB
K770737 · CDX
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
REAGENT, T-3 UPTAKE
K770738 · CDP
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
SERUM SET, THYROID CONTROL
K770739 · CDP
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
RADIOASSAY TUBES & RADIOASSAY TUBE CAPS
K770740 · JJJ
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
TOTAL THYROXINE (RIA) REAGENT SET
K770940 · CDX
The Dow Chemical Co.
Immunology · 29d
Cleared Jun 22, 1977
HUMAN REFERENCE SERUM
K770965
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Jun 17, 1977
IN VITRO FERRITIN RIA TEST
K770702 · DBF
Clinical Assays, Inc.
Immunology · 60d
Cleared Jun 14, 1977
QUANTIMUNE T-3 RIA
K770648 · CDP
Bio-Rad
Immunology · 70d
Cleared Jun 14, 1977
MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
K770687 · GRE
Microbiological Assoc.
Immunology · 62d
Cleared Jun 14, 1977
TSH RADIOIMMUNOASSAY
K770892 · JLW
Kallestad Laboratories, Inc.
Immunology · 28d