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
2905–2928 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 07, 1985
ALBUMIN BCP
K844426 · CJW
Boehringer Mannheim Corp.
Immunology · 53d
Cleared Jan 04, 1985
CORDIA T-M
K843417 · LGD
Cordis Corp.
Immunology · 126d
Cleared Jan 04, 1985
MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
K844678 · DHN
Meloy Laboratories, Inc.
Immunology · 35d
Cleared Dec 18, 1984
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · LLL
Behring Diagnostics, Inc.
Immunology · 68d
Cleared Dec 06, 1984
FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
K844105
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 44d
Cleared Dec 03, 1984
FLUOROSKAN
K842049 · JZT
Flow Laboratories, Inc.
Immunology · 195d
Cleared Nov 21, 1984
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082 · JHI
Quidel Corp.
Immunology · 33d
Cleared Nov 19, 1984
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · DBF
American Dade
Immunology · 26d
Cleared Nov 19, 1984
SERIES I/S INFECTIONS
K844289 · KTN
American Dade
Immunology · 14d
Cleared Nov 14, 1984
AGGLUTINATION TEST FOR TOTAL IGE
K843369 · DGC
Scientific Research
Immunology · 78d
Cleared Nov 01, 1984
AUTOFLOUR III SYSTEM
K841984 · DHN
Tech America Diagnostics
Immunology · 170d
Cleared Nov 01, 1984
PHARMACIA B2-MICRO RIA
K842772 · JGZ
Pharmacia, Inc.
Immunology · 108d
Cleared Nov 01, 1984
COLORZYME NDNA TEST SYSTEM
K843225 · DHN
Immuno Concepts, Inc.
Immunology · 77d
Cleared Nov 01, 1984
DNA STAT TEST KIT
K843904 · LJM
Whittaker Bioproducts, Inc.
Immunology · 29d
Cleared Oct 31, 1984
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
K843613 · GMS
Immuno-Products Industries
Immunology · 51d
Cleared Oct 30, 1984
ANTI-SCHISTOSOMA SPECIES KIT
K842660 · GNH
Amico Lab, Inc.
Immunology · 112d
Cleared Oct 30, 1984
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
K843930 · CGJ
Euro-Diagnostics BV
Immunology · 25d
Cleared Oct 25, 1984
SERATEST DNA DETERMINATION
K842563 · LKJ
Seragen Diagnostics, Inc.
Immunology · 115d
Cleared Oct 25, 1984
ADP ANA APPLEZYME
K843745 · LJM
Apple Diagnostic Products
Immunology · 30d
Cleared Oct 25, 1984
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896 · DHR
Diagnostic Products Corp.
Immunology · 22d
Cleared Oct 22, 1984
MEDICA IIF-ANTI-THYROID ANTIBODY TEST
K843343 · JZO
Medical Diagnostics, Ca.
Immunology · 56d
Cleared Oct 22, 1984
ELISA FOR TOTAL IGE
K843710 · DGC
Scientific Research
Immunology · 31d
Cleared Oct 17, 1984
ENZYGNOST ROTAVIRUS AG
K841243 · LIQ
Behring Diagnostics, Inc.
Immunology · 208d
Cleared Oct 05, 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · DHN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 39d