The following data is part of a premarket notification filed by Sienco, Inc. with the FDA for Sonoclot Coagulation & Platelet Function Analyzer.
| Device ID | K952560 |
| 510k Number | K952560 |
| Device Name: | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIENCO, INC. 557 C BURBANK ST. Broomfield, CO 80020 |
| Contact | Jon Henderson |
| Correspondent | Jon Henderson SIENCO, INC. 557 C BURBANK ST. Broomfield, CO 80020 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-02 |
| Decision Date | 1995-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B55890013181 | K952560 | 000 |
| B55890013020 | K952560 | 000 |
| B55880004320 | K952560 | 000 |
| B55880004260 | K952560 | 000 |
| B55880004250 | K952560 | 000 |
| B55880004010 | K952560 | 000 |
| B55880004001 | K952560 | 000 |