The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Unifast Activated Partial Thromboplastin Time Test.
| Device ID | K882325 |
| 510k Number | K882325 |
| Device Name: | UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST |
| Classification | Activated Partial Thromboplastin |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-06 |
| Decision Date | 1988-08-25 |