The following data is part of a premarket notification filed by American Dade with the FDA for Actin Fsl Activated Ptt Reagent.
| Device ID | K863594 |
| 510k Number | K863594 |
| Device Name: | ACTIN FSL ACTIVATED PTT REAGENT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1986-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768003882 | K863594 | 000 |
| 00842768003875 | K863594 | 000 |
| 00842768019555 | K863594 | 000 |