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

37 results for "Bio/Data Corp."
1–24 of 37
Search insights Median review: 40d Cleared: 100% Top manufacturer: Bio/Data Corp. Lead specialty: Hematology
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP
Bio/Data Corp.
Hematology · 21d
Cleared Mar 24, 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · GKP
Bio/Data Corp.
Hematology · 267d
Cleared Jun 23, 1989
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · JPA
Bio/Data Corp.
Hematology · 39d
Cleared Mar 28, 1988
KINETIC FIBRINOGEN ASSAY
K881150 · GIS
Bio/Data Corp.
Hematology · 11d
Cleared Nov 20, 1987
PLATELET EXTRACT REAGENT
K873382 · GGW
Bio/Data Corp.
Hematology · 88d
Cleared Mar 18, 1986
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · JPK
Bio/Data Corp.
Hematology · 18d
Cleared Mar 04, 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · JPA
Bio/Data Corp.
Hematology · 34d
Cleared Jan 07, 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · JPA
Bio/Data Corp.
Hematology · 55d
Cleared Oct 10, 1985
CITREX H
K853897 · GGW
Bio/Data Corp.
Hematology · 20d
Cleared Aug 13, 1985
CALCIUM CHLORIDE
K853246 · JPA
Bio/Data Corp.
Hematology · 12d
Cleared Aug 12, 1985
CITREX III
K853078 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX II
K853077 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX I
K853076 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
PLASTINEX
K852484 · GJS
Bio/Data Corp.
Hematology · 62d
Cleared Aug 12, 1985
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · GGW
Bio/Data Corp.
Hematology · 84d
Cleared Mar 26, 1985
THROMBINEX BOVINE THROMBIN
K845000 · GJA
Bio/Data Corp.
Hematology · 90d
Cleared Oct 23, 1984
REPTILASE -PC
K843207 · JCO
Bio/Data Corp.
Hematology · 69d
Cleared Feb 04, 1984
THROMBOLYTIC ACTIVITY TEST
K834301 · GJA
Bio/Data Corp.
Hematology · 57d
Cleared Jun 01, 1982
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · JBX
Bio/Data Corp.
Hematology · 50d
Cleared Sep 24, 1981
LOW FIBRINOGEN CONTROL
K812108 · KQJ
Bio/Data Corp.
Hematology · 59d
Cleared Jul 27, 1981
ARACHIDONIC ACID
K811290 · JBX
Bio/Data Corp.
Chemistry · 77d
Cleared Jul 16, 1981
THROMBIN CLOTTING TIME
K811109 · GJA
Bio/Data Corp.
Hematology · 84d
Cleared Dec 01, 1980
VON WILLEBRAND FACTOR ASSAY
K802356 · GGP
Bio/Data Corp.
Hematology · 66d
Cleared Jan 11, 1980
THROMBOKINETIC FIBRINOGEN ASSAY
K792563 · KQJ
Bio/Data Corp.
Hematology · 30d