Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Bio/Data Corp. — Predicate Candidate Screening
37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
84 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | 2000-07-12 | 21 | 0 |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | Bio/Data Corp. | 1995-03-24 | 267 | 0 |
| K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | Bio/Data Corp. | 1989-06-23 | 39 | 0 |
| K881150 | KINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1988-03-28 | 11 | 0 |
| K873382 | PLATELET EXTRACT REAGENT | Bio/Data Corp. | 1987-11-20 | 88 | 0 |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | Bio/Data Corp. | 1986-03-18 | 18 | 0 |
| K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP | Bio/Data Corp. | 1986-03-04 | 34 | 0 |
| K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P | Bio/Data Corp. | 1986-01-07 | 55 | 0 |
| K853897 | CITREX H | Bio/Data Corp. | 1985-10-10 | 20 | 0 |
| K853246 | CALCIUM CHLORIDE | Bio/Data Corp. | 1985-08-13 | 12 | 0 |
| K852484 | PLASTINEX | Bio/Data Corp. | 1985-08-12 | 62 | 0 |
| K853077 | CITREX II | Bio/Data Corp. | 1985-08-12 | 20 | 0 |
| K853076 | CITREX I | Bio/Data Corp. | 1985-08-12 | 20 | 0 |
| K852195 | CEPHALINEX ACTIVATED PTT REAGENT | Bio/Data Corp. | 1985-08-12 | 84 | 0 |
| K853078 | CITREX III | Bio/Data Corp. | 1985-08-12 | 20 | 0 |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | 1985-03-26 | 90 | 0 |
| K843207 | REPTILASE -PC | Bio/Data Corp. | 1984-10-23 | 69 | 0 |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | 1984-02-04 | 57 | 0 |
| K821005 | PLATELET AGGREGATION PROFILER #PAP-4 | Bio/Data Corp. | 1982-06-01 | 50 | 0 |
| K812108 | LOW FIBRINOGEN CONTROL | Bio/Data Corp. | 1981-09-24 | 59 | 0 |
| K811290 | ARACHIDONIC ACID | Bio/Data Corp. | 1981-07-27 | 77 | 0 |
| K811109 | THROMBIN CLOTTING TIME | Bio/Data Corp. | 1981-07-16 | 84 | 0 |
| K802356 | VON WILLEBRAND FACTOR ASSAY | Bio/Data Corp. | 1980-12-01 | 66 | 0 |
| K792563 | THROMBOKINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1980-01-11 | 30 | 0 |
| K790769 | BETA/PAK | Bio/Data Corp. | 1979-05-03 | 14 | 0 |
| K770188 | HPC TM (HEPARINIZED PLASMA CONTROL) | Bio/Data Corp. | 1977-02-18 | 21 | 0 |
| K761058 | QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT | Bio/Data Corp. | 1977-02-07 | 81 | 0 |
| K761091 | TPC-LYOPHILIZED POOLED HUMAN PLASMA | Bio/Data Corp. | 1977-02-01 | 71 | 0 |
| K760893 | AGGRECETIN | Bio/Data Corp. | 1977-01-12 | 77 | 0 |
| K761177 | SODIUM CITRATE | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761171 | VERONAL BUFFER | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761174 | PHYSIOLOGIC SALINE (0.85%) | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761175 | IMIDAZOLE BUFFER (0.05M) | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761172 | TRIS BUFFERED SALINE | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761176 | CALCIUM CHLORIDE (0.025M) | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761170 | BARBITAL SALINE BUFFER | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
| K761173 | TRIS BUFFERED | Bio/Data Corp. | 1977-01-10 | 40 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda