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
2233–2256 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 29, 1990
ELEGANCE FERRITIN ELISA
K904822 · DBF
Bioclone Australia Pty , Ltd.
Immunology · 36d
Cleared Nov 21, 1990
ALRGN SET
K903637 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 100d
Cleared Nov 21, 1990
UC IMU B
K904137 · DFC
Eucardio Laboratory, Inc.
Immunology · 76d
Cleared Nov 13, 1990
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · LKL
Reagents Applications, Inc.
Immunology · 63d
Cleared Nov 01, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
K904497 · DCN
Biotrax, Inc.
Immunology · 30d
Cleared Oct 29, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
K904498 · DHR
Biotrax, Inc.
Immunology · 27d
Cleared Oct 16, 1990
TURBIQUANT MYOGLOBIN
K903687 · DDR
Behring Diagnostics, Inc.
Immunology · 62d
Cleared Oct 15, 1990
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738 · DGC
Quidel Corp.
Immunology · 60d
Cleared Oct 15, 1990
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
K903742 · DHB
Diagnostic Products Corp.
Immunology · 61d
Cleared Oct 15, 1990
V-TREND TARGET RF TEST
K904105 · DHR
Texas Immunology, Inc.
Immunology · 39d
Cleared Oct 15, 1990
NOVA LITE TM THYROID
K904224 · JZO
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Oct 01, 1990
RHEUMAGEN CRP T-CONTROL
K904312 · DCK
Biokit USA, Inc.
Immunology · 12d
Cleared Sep 24, 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566 · JJY
Baxter Healthcare Corp
Immunology · 48d
Cleared Sep 24, 1990
MYOGLOBIN RIA TEST KIT
K904038 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 20d
Cleared Sep 24, 1990
UC IMU A
K904125 · DER
Eucardio Laboratory, Inc.
Immunology · 18d
Cleared Sep 06, 1990
ANTI-SCI-70 MICROASSAY
K902915 · LJM
Diamedix Corp.
Immunology · 65d
Cleared Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K902220 · DGR
Boehringer Mannheim Corp.
Immunology · 111d
Cleared Sep 05, 1990
QUANTA LITE TM DSDNA
K903898 · LLL
Inova Diagnostics, Inc.
Immunology · 14d
Cleared Sep 04, 1990
ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA
K902576 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Aug 30, 1990
RAPITEX(R) RF NEW
K903852 · DHR
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Aug 30, 1990
RAPITEX (R) CRP NEW
K903853 · DCN
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Aug 17, 1990
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · JZG
Pharmacia, Inc.
Immunology · 9d
Cleared Aug 14, 1990
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
K902236 · GGW
Biosearch Medical Products, Inc.
Immunology · 89d
Cleared Aug 14, 1990
ANTI-SCI-70 ANTIBODY TEST
K903314 · LLL
Immco Diagnostics, Inc.
Immunology · 21d