The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Microsample Coagulation Analyzer, Model Mca 310-c.
| Device ID | K001891 |
| 510k Number | K001891 |
| Device Name: | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C |
| Classification | Instrument, Coagulation, Automated |
| Applicant | BIO/DATA CORP. 155 GIBRALTAR RD. P.O. BOX 347 Horsham, PA 19044 -0347 |
| Contact | Rodney W Scarpelli |
| Correspondent | Rodney W Scarpelli BIO/DATA CORP. 155 GIBRALTAR RD. P.O. BOX 347 Horsham, PA 19044 -0347 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2000-07-12 |