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
1897–1920 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 20, 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · LLL
Hemagen Diagnostics, Inc.
Immunology · 134d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
K940510 · LKP
Helix Diagnostics, Inc.
Immunology · 75d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
K940588 · LKO
Helix Diagnostics, Inc.
Immunology · 71d
Cleared Mar 30, 1994
VENTANA NEGATIVE CONTROL REAGENT
K931979 · DEM
Ventana Medical Systems, Inc.
Immunology · 342d
Cleared Mar 25, 1994
SYNELISA ANA TOTAL
K935468 · LJM
Elias U.S.A., Inc.
Immunology · 133d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641 · LJM
Elias U.S.A., Inc.
Immunology · 39d
Cleared Mar 22, 1994
N-ASSAY TIA IGM
K933970 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGA
K933971 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGG
K933972 · CFF
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · DHB
Diagnostic Products Corp.
Immunology · 127d
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K926420 · DHB
Mast Immunosystems
Immunology · 439d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K934524 · DHB
Mast Immunosystems
Immunology · 168d
Cleared Jan 31, 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · LLL
Immuno Concepts, Inc.
Immunology · 95d
Cleared Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · DHR
Theratest Laboratories, Inc.
Immunology · 182d
Cleared Jan 28, 1994
N-ASSAY TIA MULTI V-NL
K933973 · CFN
Crestat Diagnostics, Inc.
Immunology · 168d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · DBF
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 73d
Cleared Jan 24, 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · MID
Elias U.S.A., Inc.
Immunology · 82d
Cleared Jan 13, 1994
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
K930796 · JZX
Alko Diagnostic Corp.
Immunology · 331d
Cleared Jan 11, 1994
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
K933078 · MGA
Beckman Instruments, Inc.
Immunology · 202d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966 · DDS
Incstar Corp.
Immunology · 88d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075 · DCN
Incstar Corp.
Immunology · 78d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778 · KTN
Meridian Diagnostics, Inc.
Immunology · 314d
Cleared Dec 21, 1993
QUANTA LITE(TM) HISTONE ELISA
K934053 · LLL
Inova Diagnostics, Inc.
Immunology · 124d