Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
2233–2256 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 07, 1990
DIASTAT ANTI-SM/RNP
K905192 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Nov 29, 1990
IVT RAST TRACER
K904661 · DHB
In Vitro Technologies, Inc.
Immunology · 48d
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