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
2209–2232 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 05, 1991
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
K910517 · DHB
Pharmacia, Inc.
Immunology · 28d
Cleared Feb 21, 1991
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
K905612 · DGC
Ventrex Laboratories, Inc.
Immunology · 69d
Cleared Feb 07, 1991
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K905636 · DHB
Ventrex Laboratories, Inc.
Immunology · 52d
Cleared Jan 30, 1991
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · CEE
Immunotech Corp.
Immunology · 34d
Cleared Jan 30, 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075 · DHB
Diagnostic Products Corp.
Immunology · 22d
Cleared Jan 25, 1991
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
K903531 · GFO
Medical Innovations Corp.
Immunology · 172d
Cleared Jan 25, 1991
IMMUNOWELL THYROGLOBULIN TEST
K905485 · JZO
General Biometrics, Inc.
Immunology · 50d
Cleared Jan 25, 1991
LUPUS(LE)-LATEX TEST
K905531 · LKI
Immco Diagnostics, Inc.
Immunology · 46d
Cleared Jan 25, 1991
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033 · LJM
United Biotech, Inc.
Immunology · 21d
Cleared Jan 14, 1991
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
K905162 · DHB
Quidel Corp.
Immunology · 59d
Cleared Jan 14, 1991
THE THERATEST ACA TEST
K905301 · GFO
Theratest Laboratories, Inc.
Immunology · 48d
Cleared Jan 03, 1991
TITAN GEL
K905149 · DAH
Helena Laboratories
Immunology · 49d
Cleared Jan 03, 1991
IMMUNOWELL TPO (MICROSOME) TEST
K905486 · JNL
General Biometrics, Inc.
Immunology · 28d
Cleared Dec 18, 1990
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · CDP
Immunotech Corp.
Immunology · 55d
Cleared Dec 13, 1990
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176 · DHB
Quidel Corp.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-LA (SS-B)
K905193 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-RO (SS-A)
K905194 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
TURBIQUANT MYOGLOBIN
K905202 · DDR
Behring Diagnostics, Inc.
Immunology · 23d
Cleared Dec 13, 1990
DISTAT ANTI-DSDNA KIT
K905386 · KTL
Shield Diagnostics, Ltd.
Immunology · 13d
Cleared Dec 07, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K904330 · DHB
Ventrex Laboratories, Inc.
Immunology · 78d
Cleared Dec 07, 1990
DIASTAT ENA PROFILE
K905190 · LJM
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM
K905191 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
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