Bio/Data Corp.
Medical device manufacturer in Horsham, PA.
37510(k) clearances
0PMA approvals
0recalls
Device types
- JPA System, Multipurpose For In Vitro… 13
- GJA Test, Thrombin Time 3
- GGW Test, Time, Partial Thromboplastin 3
- JCE Solution, Isotonic 2
- JOZ System, Automated Platelet Aggregation 2
- GGP Test, Qualitative And Quantitative Factor… 2
- KQJ System, Fibrinogen Determination 2
- JBX Aggregrometer, Platelet 2
- GKP Instrument, Coagulation, Automated 2
- GJE Tray, Blood Collection 1
- GGC Control, Plasma, Abnormal 1
- JCO Bothrops Atrox Reagent 1
- GJS Test, Time, Prothrombin 1
- JPK Mixture, Hematology Quality Control 1
- GIS Test, Fibrinogen 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K001891 | Microsample Coagulation Analyzer, Model Mca 310-CGKP · Special | 07/12/2000SE |
| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | 03/24/1995SE |
| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | 11/20/1987SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
| K853078 | Citrex IIIJPA · Traditional | 08/12/1985SE |
| K853077 | Citrex IIJPA · Traditional | 08/12/1985SE |
| K853076 | Citrex IJPA · Traditional | 08/12/1985SE |
| K852484 | PlastinexGJS · Traditional | 08/12/1985SE |
| K852195 | Cephalinex Activated PTT ReagentGGW · Traditional | 08/12/1985SE |
| K845000 | Thrombinex Bovine ThrombinGJA · Traditional | 03/26/1985SE |
| K843207 | Reptilase -PcJCO · Traditional | 10/23/1984SE |
| K834301 | Thrombolytic Activity TestGJA · Traditional | 02/04/1984SE |
| K821005 | Platelet Aggregation Profiler #PAP-4JBX · Traditional | 06/01/1982SE |
| K812108 | Low Fibrinogen ControlKQJ · Traditional | 09/24/1981SE |
| K811290 | Arachidonic AcidJBX · Traditional | 07/27/1981SE |
| K811109 | Thrombin Clotting TimeGJA · Traditional | 07/16/1981SE |
| K802356 | Von Willebrand Factor AssayGGP · Traditional | 12/01/1980SE |
| K792563 | Thrombokinetic Fibrinogen AssayKQJ · Traditional | 01/11/1980SE |
| K790769 | Beta/PakJOZ · Traditional | 05/03/1979SE |
| K770188 | HPC TM (Heparinized Plasma Control)GGC · Traditional | 02/18/1977SE |
| K761058 | QUAN-8 Mult-Comp Factor Viii Assay KitGGP · Traditional | 02/07/1977SE |
| K761091 | Tpc-Lyophilized Pooled Human PlasmaJPA · Traditional | 02/01/1977SE |
| K760893 | AggrecetinJOZ · Traditional | 01/12/1977SE |
| K761177 | Sodium CitrateGJE · Traditional | 01/10/1977SE |
| K761176 | Calcium Chloride (0.025M)JPA · Traditional | 01/10/1977SE |
| K761175 | Imidazole Buffer (0.05M)JPA · Traditional | 01/10/1977SE |
| K761174 | Physiologic Saline (0.85%)JCE · Traditional | 01/10/1977SE |
| K761173 | Tris BufferedJPA · Traditional | 01/10/1977SE |
| K761172 | Tris Buffered SalineJPA · Traditional | 01/10/1977SE |
| K761171 | Veronal BufferJPA · Traditional | 01/10/1977SE |
| K761170 | Barbital Saline BufferJCE · Traditional | 01/10/1977SE |