The following data is part of a premarket notification filed by Sienco, Inc. with the FDA for Sonoclot Coagulation & Platelet Function Analyzer System With Signature Viewer Option.
| Device ID | K002528 |
| 510k Number | K002528 |
| Device Name: | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | SIENCO, INC. 11485-A WEST 48TH AVE. Wheat Ridge, CO 80033 |
| Contact | Barbara Debiase |
| Correspondent | Barbara Debiase SIENCO, INC. 11485-A WEST 48TH AVE. Wheat Ridge, CO 80033 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-16 |
| Decision Date | 2000-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B558DP29510 | K002528 | 000 |