Medical Device Manufacturer · US , Mchenry , IL

Bio/Data Corp.

37 submissions · 37 cleared · Since 1977
37
Total
37
Cleared
0
Denied

Bio/Data Corp. — FDA 510(k) Submissions

Bio/Data Corp. has submitted 37 FDA 510(k) premarket notifications since 1977, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, Test, Thrombin Time, Test, Time, Partial Thromboplastin, System, Fibrinogen Determination, Aggregrometer, Platelet . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP Instrument, Coagulation,... · Hematology
Jul 2000 21d
MICROSAMPLE COAGULATION ANALYZER
K943153 · GKP Instrument, Coagulation,... · Hematology
Mar 1995 267d
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · JPA System, Multipurpose For... · Hematology
Jun 1989 39d
KINETIC FIBRINOGEN ASSAY
K881150 · GIS Test, Fibrinogen · Hematology
Mar 1988 11d
PLATELET EXTRACT REAGENT
K873382 · GGW Test, Time, Partial... · Hematology
Nov 1987 88d
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · JPK Mixture, Hematology... · Hematology
Mar 1986 18d
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · JPA System, Multipurpose For... · Hematology
Mar 1986 34d
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · JPA System, Multipurpose For... · Hematology
Jan 1986 55d
CITREX H
K853897 · GGW Test, Time, Partial... · Hematology
Oct 1985 20d
CALCIUM CHLORIDE
K853246 · JPA System, Multipurpose For... · Hematology
Aug 1985 12d
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · GGW Test, Time, Partial... · Hematology
Aug 1985 84d
PLASTINEX
K852484 · GJS Test, Time, Prothrombin · Hematology
Aug 1985 62d
CITREX I
K853076 · JPA System, Multipurpose For... · Hematology
Aug 1985 20d
CITREX II
K853077 · JPA System, Multipurpose For... · Hematology
Aug 1985 20d
CITREX III
K853078 · JPA System, Multipurpose For... · Hematology
Aug 1985 20d
THROMBINEX BOVINE THROMBIN
K845000 · GJA Test, Thrombin Time · Hematology
Mar 1985 90d
REPTILASE -PC
K843207 · JCO Bothrops Atrox Reagent · Hematology
Oct 1984 69d
THROMBOLYTIC ACTIVITY TEST
K834301 · GJA Test, Thrombin Time · Hematology
Feb 1984 57d
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · JBX Aggregrometer, Platelet · Hematology
Jun 1982 50d
LOW FIBRINOGEN CONTROL
K812108 · KQJ System, Fibrinogen... · Hematology
Sep 1981 59d
ARACHIDONIC ACID
K811290 · JBX Aggregrometer, Platelet · Chemistry
Jul 1981 77d
THROMBIN CLOTTING TIME
K811109 · GJA Test, Thrombin Time · Hematology
Jul 1981 84d
VON WILLEBRAND FACTOR ASSAY
K802356 · GGP Test, Qualitative And... · Hematology
Dec 1980 66d
THROMBOKINETIC FIBRINOGEN ASSAY
K792563 · KQJ System, Fibrinogen... · Hematology
Jan 1980 30d
BETA/PAK
K790769 · JOZ System, Automated... · Hematology
May 1979 14d
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