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
1681–1704 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 29, 1996
QUANTA LITE SSDNA
K954380 · LJM
Inova Diagnostics, Inc.
Immunology · 163d
Cleared Feb 27, 1996
CHEMMATE SPECIAL STAIN LCA-CD45
K936111 · DEH
Biotek Solutions, Inc.
Immunology · 796d
Cleared Feb 26, 1996
KERATIN PRIMARY ANTIBODY
K940331 · DEH
Ventana Medical Systems, Inc.
Immunology · 763d
Cleared Feb 21, 1996
N PROTEIN STANDARS SY
K955857 · CZW
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 21, 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858 · JJY
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 16, 1996
WAKO AUTOKIT CRP NEW
K955156 · DCK
Wako Chemicals USA, Inc.
Immunology · 95d
Cleared Feb 16, 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · KLT
Beckman Instruments, Inc.
Immunology · 66d
Cleared Feb 14, 1996
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · DCN
Olympus America, Inc.
Immunology · 138d
Cleared Feb 14, 1996
IMMILITE TOTAL IGE
K960067 · JHR
Diagnostic Products Corp.
Immunology · 40d
Cleared Feb 09, 1996
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CARDIOLIPIN IGG EIA TEST KIT
K952523 · MID
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGG ASSAY
K955906 · DFZ
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907 · CZP
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGM ASSAY
K955908 · DAO
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Jan 30, 1996
PHARMACIA CAP SYSTEM PHADIATOP FEIA
K941993 · DHB
Pharmacia, Inc.
Immunology · 645d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
K946068 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
K946069 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 26, 1996
VARELISA PR3-ANCA
K953586 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 26, 1996
VARELISA MPO-ANCA
K953587 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 24, 1996
CARDIOLIPIN G EIA TEST SYSTEM
K946215 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · MID
Hogan & Hartson
Immunology · 399d