Bio/Data Corp.
Horsham, PA, US
Bio/Data Corp. appears in FDA device records in Horsham, PA. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Bio/Data Corp. between 1977 and 2000. The busiest year on record is 1977, with 12. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 12 |
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 3 |
| 1982 | 1 |
| 1984 | 2 |
| 1985 | 8 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1995 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | GKP | Substantially Equivalent | |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | GKP | Substantially Equivalent | |
| K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | JPA | Substantially Equivalent | |
| K881150 | KINETIC FIBRINOGEN ASSAY | GIS | Substantially Equivalent | |
| K873382 | PLATELET EXTRACT REAGENT | GGW | Substantially Equivalent | |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | JPK | Substantially Equivalent | |
| K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP | JPA | Substantially Equivalent | |
| K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P | JPA | Substantially Equivalent | |
| K853897 | CITREX H | GGW | Substantially Equivalent | |
| K853246 | CALCIUM CHLORIDE | JPA | Substantially Equivalent | |
| K853078 | CITREX III | JPA | Substantially Equivalent | |
| K853077 | CITREX II | JPA | Substantially Equivalent | |
| K853076 | CITREX I | JPA | Substantially Equivalent | |
| K852484 | PLASTINEX | GJS | Substantially Equivalent | |
| K852195 | CEPHALINEX ACTIVATED PTT REAGENT | GGW | Substantially Equivalent | |
| K845000 | THROMBINEX BOVINE THROMBIN | GJA | Substantially Equivalent | |
| K843207 | REPTILASE -PC | JCO | Substantially Equivalent | |
| K834301 | THROMBOLYTIC ACTIVITY TEST | GJA | Substantially Equivalent | |
| K821005 | PLATELET AGGREGATION PROFILER #PAP-4 | JBX | Substantially Equivalent | |
| K812108 | LOW FIBRINOGEN CONTROL | KQJ | Substantially Equivalent | |
| K811290 | ARACHIDONIC ACID | JBX | Substantially Equivalent | |
| K811109 | THROMBIN CLOTTING TIME | GJA | Substantially Equivalent | |
| K802356 | VON WILLEBRAND FACTOR ASSAY | GGP | Substantially Equivalent | |
| K792563 | THROMBOKINETIC FIBRINOGEN ASSAY | KQJ | Substantially Equivalent | |
| K790769 | BETA/PAK | JOZ | Substantially Equivalent | |
| K770188 | HPC TM (HEPARINIZED PLASMA CONTROL) | GGC | Substantially Equivalent | |
| K761058 | QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT | GGP | Substantially Equivalent | |
| K761091 | TPC-LYOPHILIZED POOLED HUMAN PLASMA | JPA | Substantially Equivalent | |
| K760893 | AGGRECETIN | JOZ | Substantially Equivalent | |
| K761177 | SODIUM CITRATE | GJE | Substantially Equivalent | |
| K761176 | CALCIUM CHLORIDE (0.025M) | JPA | Substantially Equivalent | |
| K761175 | IMIDAZOLE BUFFER (0.05M) | JPA | Substantially Equivalent | |
| K761174 | PHYSIOLOGIC SALINE (0.85%) | JCE | Substantially Equivalent | |
| K761173 | TRIS BUFFERED | JPA | Substantially Equivalent | |
| K761172 | TRIS BUFFERED SALINE | JPA | Substantially Equivalent | |
| K761171 | VERONAL BUFFER | JPA | Substantially Equivalent | |
| K761170 | BARBITAL SALINE BUFFER | JCE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JBXAggregrometer, Platelet
- JCOBothrops Atrox Reagent
- GGCControl, Plasma, Abnormal
- GKPInstrument, Coagulation, Automated
- JPKMixture, Hematology Quality Control
- JCESolution, Isotonic
- JOZSystem, Automated Platelet Aggregation
- KQJSystem, Fibrinogen Determination
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GISTest, Fibrinogen
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- GJETray, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain