The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Actin, Activated Cephaloplastin Reagent.
| Device ID | K760318 |
| 510k Number | K760318 |
| Device Name: | ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-26 |
| Decision Date | 1976-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768003851 | K760318 | 000 |
| 00842768003837 | K760318 | 000 |
| 00842768019579 | K760318 | 000 |