Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1129–1152 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
K992790 · JZO
Brahms Diagnostica, LLC
Immunology · 85d
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
K992791 · JZO
Brahms Diagnostica, LLC
Immunology · 85d
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