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
3625–3648 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 02, 1977
AFT SYSTEM
K771993 · DBM
Calbiochem
Immunology · 12d
Cleared Nov 02, 1977
PLATES FOR HUMAN C4 COMPLEMENT
K772002 · DBI
G.D. Searle and Co.
Immunology · 12d
Cleared Nov 02, 1977
AMES T-4 STRIP TEST
K772014 · CDX
Miles Laboratories, Inc.
Immunology · 8d
Cleared Oct 21, 1977
DIGOXIN RIA KIT
K771877 · DNJ
Antibodies, Inc.
Immunology · 17d
Cleared Oct 19, 1977
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
K771879 · DEN
Hyland Therapeutic Div., Travenol...
Immunology · 15d
Cleared Oct 19, 1977
LAS-R BETA LIPOPROTEIN TEST
K771912 · DFC
Hyland Therapeutic Div., Travenol...
Immunology · 8d
Cleared Oct 18, 1977
IFA ANTI-NDNA
K771376 · DHN
Electro-Nucleonics Laboratories, Inc.
Immunology · 85d
Cleared Oct 18, 1977
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
K771812 · DFC
Gelman Instrument Co.
Immunology · 21d
Cleared Oct 14, 1977
PTH RIA
K771783 · CEW
Nichols Institute Diagnostics
Immunology · 21d
Cleared Oct 07, 1977
T3U
K771766
Union Carbide Corp.
Immunology · 18d
Cleared Oct 07, 1977
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM
K771768 · DEH
G.D. Searle and Co.
Immunology · 18d
Cleared Oct 07, 1977
QUAN. COLOR. DETER. OF SERUM ALBUMIN
K771771 · DCF
Stanbio Laboratory
Immunology · 18d
Cleared Oct 04, 1977
LAS-R TM
K771780 · DEB
Hyland Therapeutic Div., Travenol...
Immunology · 11d
Cleared Sep 15, 1977
IMMOCHEMISTRY SYSTEM
K771603 · CZP
Beckman Instruments, Inc.
Immunology · 24d
Cleared Sep 02, 1977
RHEUMANOSTICON R
K771410 · DHR
Organon, Inc.
Immunology · 32d
Cleared Sep 02, 1977
LAS-R HUMAN CRP TEST
K771535 · DCN
Hyland Therapeutic Div., Travenol...
Immunology · 23d
Cleared Aug 25, 1977
AGGLUTINATING SERUM W135
K771562 · GTJ
Burroughs Wellcome Co.
Immunology · 10d
Cleared Aug 22, 1977
MONOSTICON TEST
K771397 · KTN
Organon, Inc.
Immunology · 24d
Cleared Aug 04, 1977
ANTI-MITOCHONDRIAL
K771155 · DBE
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Aug 03, 1977
GAMMA GOUNTING SYS., AUTO, MODEL 1400
K771180 · JJJ
G.D. Searle and Co.
Immunology · 34d
Cleared Aug 03, 1977
TRIOBEAD-125 DIAGNOSTIC KIT
K771236 · CEC
Abbott Laboratories
Immunology · 23d
Cleared Aug 02, 1977
GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM
K771239
G.D. Searle and Co.
Immunology · 22d
Cleared Jul 15, 1977
RID PLATES & INTENSI. FOR HUMAN IGE ETC
K771238 · DGC
G.D. Searle and Co.
Immunology · 4d
Cleared Jul 14, 1977
QUANTIMUNE NEONATAL & THYROXINE RIA
K771135 · CDX
Bio-Rad
Immunology · 21d