The following data is part of a premarket notification filed by American Dade with the FDA for Actin Fs Activated Ptt Reagent.
| Device ID | K811589 |
| 510k Number | K811589 |
| Device Name: | ACTIN FS ACTIVATED PTT REAGENT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | AMERICAN DADE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-08 |
| Decision Date | 1981-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768003868 | K811589 | 000 |
| 00842768003844 | K811589 | 000 |
| 00842768019562 | K811589 | 000 |