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
1993–2016 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 16, 1993
QUANTA LITE(TM) THYROID M ELISA
K930485 · JZO
Inova Diagnostics, Inc.
Immunology · 46d
Cleared Mar 15, 1993
QUANTA LITE(TM) THYROID T ELISA
K930486 · DDC
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Mar 10, 1993
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
K930247 · DHC
The Binding Site, Ltd.
Immunology · 50d
Cleared Mar 10, 1993
ELIAS DSDNA ABS
K930421 · DHC
Elias U.S.A., Inc.
Immunology · 43d
Cleared Mar 10, 1993
TINA-QUANT CRP
K930621 · DCK
Boehringer Mannheim Corp.
Immunology · 30d
Cleared Mar 04, 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562 · LLL
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Feb 23, 1993
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 225d
Cleared Feb 23, 1993
CANCER ANTIGEN CONTROL
K924061 · JJY
Polymedco, Inc.
Immunology · 195d
Cleared Feb 23, 1993
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · CFF
The Binding Site, Ltd.
Immunology · 153d
Cleared Feb 23, 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · CFF
The Binding Site, Ltd.
Immunology · 153d
Cleared Feb 23, 1993
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
K925183 · KTN
Princeton Biomedix
Immunology · 132d
Cleared Feb 23, 1993
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
K930274 · JZO
Joldon Diagnostics
Immunology · 35d
Cleared Feb 17, 1993
TANDEM-E IGE II CALIBRATION VERIFICATION SET
K922754 · JJX
Hybritech, Inc.
Immunology · 254d
Cleared Feb 05, 1993
IL TEST CALIBRATION SET APO A1B
K923079 · DFC
Instrumentation Laboratory CO
Immunology · 225d
Cleared Feb 05, 1993
PSA ANTIBODY KIT
K924578 · DFD
Ventana Medical Systems, Inc.
Immunology · 148d
Cleared Feb 05, 1993
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
K925194 · JZO
Joldon Diagnostics
Immunology · 113d
Cleared Feb 04, 1993
PAP ANTIBODY KIT
K924629 · DFD
Ventana Medical Systems, Inc.
Immunology · 143d
Cleared Feb 02, 1993
EN TYPING CIE KIT FOR DIAGNOSTIC USE
K925118 · LLL
The Binding Site, Ltd.
Immunology · 162d
Cleared Jan 26, 1993
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
K925826 · JZO
Clark Laboratories, Inc.
Immunology · 71d
Cleared Jan 21, 1993
AUTOSTAT ANTITHYROGLOBIN
K925784 · JZO
Cogent Diagnotics , Ltd.
Immunology · 79d
Cleared Jan 21, 1993
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K925785 · JZO
Cogent Diagnotics , Ltd.
Immunology · 79d
Cleared Jan 14, 1993
SPECIFIC IGE EIA-TURBO ASSAY
K925425 · DHB
Hycor Biomedical, Inc.
Immunology · 79d
Cleared Jan 14, 1993
ELIAS TGAB
K925922 · JZO
Elias U.S.A., Inc.
Immunology · 52d
Cleared Jan 14, 1993
ELIAS TMAB
K925923 · JZO
Elias U.S.A., Inc.
Immunology · 52d