Company ยท US
Bio/Data Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2000. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 13 |
| GGW | Test, Time, Partial Thromboplastin | 3 |
| GJA | Test, Thrombin Time | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 |
| GKP | Instrument, Coagulation, Automated | 2 |
| JBX | Aggregrometer, Platelet | 2 |
| JCE | Solution, Isotonic | 2 |
| JOZ | System, Automated Platelet Aggregation | 2 |
| KQJ | System, Fibrinogen Determination | 2 |
| GGC | Control, Plasma, Abnormal | 1 |
| GIS | Test, Fibrinogen | 1 |
| GJE | Tray, Blood Collection | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JCO | Bothrops Atrox Reagent | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2000 | K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C Bio/Data Corp. | GKP |
| Mar 24, 1995 | K943153 | MICROSAMPLE COAGULATION ANALYZER Bio/Data Corp. | GKP |
| Jun 23, 1989 | K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C Bio/Data Corp. | JPA |
| Mar 28, 1988 | K881150 | KINETIC FIBRINOGEN ASSAY Bio/Data Corp. | GIS |
| Nov 20, 1987 | K873382 | PLATELET EXTRACT REAGENT Bio/Data Corp. | GGW |
| Mar 18, 1986 | K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA Bio/Data Corp. | JPK |
| Mar 4, 1986 | K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP Bio/Data Corp. | JPA |
| Jan 7, 1986 | K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P Bio/Data Corp. | JPA |
| Oct 10, 1985 | K853897 | CITREX H Bio/Data Corp. | GGW |
| Aug 13, 1985 | K853246 | CALCIUM CHLORIDE Bio/Data Corp. | JPA |
| Aug 12, 1985 | K853078 | CITREX III Bio/Data Corp. | JPA |
| Aug 12, 1985 | K853077 | CITREX II Bio/Data Corp. | JPA |
| Aug 12, 1985 | K853076 | CITREX I Bio/Data Corp. | JPA |
| Aug 12, 1985 | K852484 | PLASTINEX Bio/Data Corp. | GJS |
| Aug 12, 1985 | K852195 | CEPHALINEX ACTIVATED PTT REAGENT Bio/Data Corp. | GGW |
| Mar 26, 1985 | K845000 | THROMBINEX BOVINE THROMBIN Bio/Data Corp. | GJA |
| Oct 23, 1984 | K843207 | REPTILASE -PC Bio/Data Corp. | JCO |
| Feb 4, 1984 | K834301 | THROMBOLYTIC ACTIVITY TEST Bio/Data Corp. | GJA |
| Jun 1, 1982 | K821005 | PLATELET AGGREGATION PROFILER #PAP-4 Bio/Data Corp. | JBX |
| Sep 24, 1981 | K812108 | LOW FIBRINOGEN CONTROL Bio/Data Corp. | KQJ |
| Jul 27, 1981 | K811290 | ARACHIDONIC ACID Bio/Data Corp. | JBX |
| Jul 16, 1981 | K811109 | THROMBIN CLOTTING TIME Bio/Data Corp. | GJA |
| Dec 1, 1980 | K802356 | VON WILLEBRAND FACTOR ASSAY Bio/Data Corp. | GGP |
| Jan 11, 1980 | K792563 | THROMBOKINETIC FIBRINOGEN ASSAY Bio/Data Corp. | KQJ |
| May 3, 1979 | K790769 | BETA/PAK Bio/Data Corp. | JOZ |
| Feb 18, 1977 | K770188 | HPC TM (HEPARINIZED PLASMA CONTROL) Bio/Data Corp. | GGC |
| Feb 7, 1977 | K761058 | QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT Bio/Data Corp. | GGP |
| Feb 1, 1977 | K761091 | TPC-LYOPHILIZED POOLED HUMAN PLASMA Bio/Data Corp. | JPA |
| Jan 12, 1977 | K760893 | AGGRECETIN Bio/Data Corp. | JOZ |
| Jan 10, 1977 | K761177 | SODIUM CITRATE Bio/Data Corp. | GJE |
| Jan 10, 1977 | K761176 | CALCIUM CHLORIDE (0.025M) Bio/Data Corp. | JPA |
| Jan 10, 1977 | K761175 | IMIDAZOLE BUFFER (0.05M) Bio/Data Corp. | JPA |
| Jan 10, 1977 | K761174 | PHYSIOLOGIC SALINE (0.85%) Bio/Data Corp. | JCE |
| Jan 10, 1977 | K761173 | TRIS BUFFERED Bio/Data Corp. | JPA |
| Jan 10, 1977 | K761172 | TRIS BUFFERED SALINE Bio/Data Corp. | JPA |
| Jan 10, 1977 | K761171 | VERONAL BUFFER Bio/Data Corp. | JPA |
| Jan 10, 1977 | K761170 | BARBITAL SALINE BUFFER Bio/Data Corp. | JCE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||