The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Microsample Coagulation Analyzer.
| Device ID | K943153 |
| 510k Number | K943153 |
| Device Name: | MICROSAMPLE COAGULATION ANALYZER |
| Classification | Instrument, Coagulation, Automated |
| Applicant | BIO/DATA CORP. 155 CENTENNIAL PLAZA Horsham, PA 19044 |
| Contact | Rodney W Scarpelli |
| Correspondent | Rodney W Scarpelli BIO/DATA CORP. 155 CENTENNIAL PLAZA Horsham, PA 19044 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-30 |
| Decision Date | 1995-03-24 |