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
1657–1680 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
K954815 · LJM
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
K954829 · LJM
Orgentec
Immunology · 181d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
K954832 · LJM
Orgentec
Immunology · 181d
Cleared Apr 10, 1996
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
K953495 · DBL
Scimedx Corp.
Immunology · 259d
Cleared Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794 · CZP
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · DFT
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · DEW
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Mar 22, 1996
KERATIN PRIMARY ANTIBODY
K935161 · DEH
Ventana Medical Systems, Inc.
Immunology · 875d
Cleared Mar 22, 1996
ANTI-KERATIN-HMW PRIMARY ANTI-BODY
K941173 · DEH
Ventana Medical Systems, Inc.
Immunology · 739d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896 · LKP
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · LKO
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
RETINOL BINDING RID KIT
K955881 · CZS
The Binding Site, Ltd.
Immunology · 85d
Cleared Mar 20, 1996
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · LRM
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · LLL
Hycor Biomedical, Inc.
Immunology · 183d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KIT (JO-1)
K954895 · LLL
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K960091 · LRM
Helix Diagnostics, Inc.
Immunology · 69d
Cleared Mar 20, 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
K960182 · LRM
Mardx Diagnostics, Inc.
Immunology · 64d
Cleared Mar 19, 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062 · MOB
Scimedx Corp.
Immunology · 203d
Cleared Mar 19, 1996
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105 · MOB
Scimedx Corp.
Immunology · 201d
Cleared Mar 19, 1996
QUANTA LITE PR3
K955021 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 19, 1996
QUANTA LITE MPO
K955022 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 13, 1996
PSA CONTROLS
K960154 · JJX
Diagnostic Products Corp.
Immunology · 57d