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
2209–2232 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 06, 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · JZG
Diagnostic Products Corp.
Immunology · 58d
Cleared Mar 06, 1991
HEMAGEN ENA SCREENING KIT
K910232 · LLL
Hemagen Diagnostics, Inc.
Immunology · 47d
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