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
3769–3792 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 26, 1976
TEST, MACROGLOBULIN KIT (ALPHA2)
K760396
Kallestad Laboratories, Inc.
Immunology · 20d
Cleared Aug 11, 1976
TEST, SLIDE FOR C-REATIVE PROTEIN
K760354 · DCK
Icl Scientific
Immunology · 9d
Cleared Aug 03, 1976
TEST, MONO., DIFFERENTIAL SLIDE
K760032 · KIN
Gamma Biologicals, Inc.
Immunology · 50d
Cleared Aug 03, 1976
TEST, C-REATIVE PROTEIN, LATEX SLIDE
K760035 · DCK
Gamma Biologicals, Inc.
Immunology · 50d
Cleared Aug 03, 1976
TEST, LATEX SLIDE, RHEUMATOID FACTOR
K760036 · DHR
Gamma Biologicals, Inc.
Immunology · 50d
Cleared Aug 03, 1976
TEST, MONO., CARD (MACRO-VUE)
K760040 · KTN
Bd Becton Dickinson Vacutainer...
Immunology · 49d
Cleared Aug 03, 1976
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 49d
Cleared Aug 03, 1976
TEST, DETECTION, ANTINUCLEAR ANTIBODIES
K760206 · DHN
Intl. Diagnostic Technology
Immunology · 25d
Cleared Jul 26, 1976
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209 · DHN
Zeus Scientific, Inc.
Immunology · 17d
Cleared Jul 26, 1976
RADIOIMMUNOASSAY
K760227 · CDX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Jul 20, 1976
TEST, IN-VITRO DIAGNOSTIC
K760089
Hoffmann-La Roche, Inc.
Immunology · 29d
Cleared Jul 20, 1976
TEST, RIA, TSH QUANTIMUNE
K760132 · JLW
Bio-Rad
Immunology · 22d
Cleared Jul 20, 1976
TEST, RA, QUANTA-COUNT T-4
K760135 · CDX
Bio-Rad
Immunology · 22d
Cleared Jul 20, 1976
SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
K760143 · DEX
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID
K760144 · DAD
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, IGA GOAT ANTI-HUMAN ACID
K760146 · CZP
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, IGM ANTI-HUMAN ACID
K760147 · DFT
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
K760148 · CZW
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
TEST, (IVDP) ANTINUCLEAR ANTIBODY
K760153 · DHN
Zeus Scientific, Inc.
Immunology · 18d
Cleared Jul 20, 1976
TEST, (IVDP) THYROID ANTIBODY
K760154 · JZO
Zeus Scientific, Inc.
Immunology · 18d
Cleared Jul 20, 1976
TEST, (IVDP) MITOCHONDRIAL ANTIBODY
K760155 · DBM
Zeus Scientific, Inc.
Immunology · 18d
Cleared Jul 20, 1976
TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
K760156 · DBE
Zeus Scientific, Inc.
Immunology · 18d
Cleared Jul 19, 1976
SERUM, IGG GOAT ANTI-HUMAN ACID
K760145 · DEW
Oxford Laboratories, Inc.
Immunology · 20d
Cleared Jul 19, 1976
ACCUVETTE II
K760197 · JRI
Coulter Electronics, Inc.
Immunology · 13d