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
1993–2016 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 22, 1993
AUTOSTAT ANTI-DSDNA
K925783 · JJX
Cogent Diagnotics , Ltd.
Immunology · 140d
Cleared Mar 18, 1993
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · DHX
Tosoh Medics, Inc.
Immunology · 171d
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