The following data is part of a premarket notification filed by Diatech, Inc. with the FDA for Diatimer-1 Blood Plasma Clot Timing Instrument.
| Device ID | K854089 |
| 510k Number | K854089 |
| Device Name: | DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DIATECH, INC. 4101 S. HOSPITAL DR. Fort Lauderdale, FL 33317 |
| Contact | Betty L White |
| Correspondent | Betty L White DIATECH, INC. 4101 S. HOSPITAL DR. Fort Lauderdale, FL 33317 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1986-01-06 |