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
1129–1152 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · MST
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · MST
Cogent Diagnotics , Ltd.
Immunology · 58d
Cleared Nov 12, 1999
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
K993108 · LJM
Pharmacia & Upjohn Co.
Immunology · 56d
Cleared Nov 12, 1999
VARELISA RECOMBI ANA PROFILE
K993109 · LJM
Pharmacia & Upjohn Co.
Immunology · 56d
Cleared Nov 12, 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · DDG
Wako Chemicals USA, Inc.
Immunology · 51d
Cleared Nov 12, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250 · MST
Zeus Scientific, Inc.
Immunology · 45d
Cleared Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632 · CGA
Selfcare, Inc.
Immunology · 16d
Cleared Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · CZW
Bayer Corp.
Immunology · 155d
Cleared Nov 09, 1999
LYPHOCHEK ANEMIA CONTROL, MODEL 500
K992741 · JJY
Bio-Rad
Immunology · 85d
Cleared Nov 09, 1999
K-ASSAY IGG
K993281 · DEW
Kamiya Biomedical Co.
Immunology · 40d
Cleared Nov 01, 1999
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA)...
K993034 · MVM
Medica, Inc.
Immunology · 53d
Cleared Oct 25, 1999
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385 · DCK
Dade Behring, Inc.
Immunology · 187d
Cleared Oct 25, 1999
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · LKJ
Diamedix Corp.
Immunology · 24d
Cleared Oct 15, 1999
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
K992878 · MVM
Immco Diagnostics, Inc.
Immunology · 50d
Cleared Sep 24, 1999
BIOCHECK FERRITIN ELISA MODEL BC-1025
K992517 · DBF
Biocheck, Inc.
Immunology · 58d
Cleared Sep 21, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · MID
Cogent Diagnotics , Ltd.
Immunology · 61d
Cleared Sep 21, 1999
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · DGC
Biocheck, Inc.
Immunology · 55d
Cleared Sep 17, 1999
TOTAL HAEMOLYTIC COMPLEMENT RID KIT
K992488 · DAE
The Binding Site, Ltd.
Immunology · 53d
Cleared Sep 13, 1999
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
K992312 · DCK
Kamiya Biomedical Co.
Immunology · 66d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 24, 1999
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942 · MLE
Cogent Diagnotics , Ltd.
Immunology · 76d
Cleared Aug 09, 1999
TOUCH TEAR IGE MICROASSAY KIT
K991316 · DGC
Touch Scientific, Inc.
Immunology · 112d