The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thromboscreen Aptt Reagent.
| Device ID | K891337 |
| 510k Number | K891337 |
| Device Name: | THROMBOSCREEN APTT REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Contact | Furman, Phd |
| Correspondent | Furman, Phd PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000771 | K891337 | 000 |
| 00845275000764 | K891337 | 000 |
| 00845275000665 | K891337 | 000 |
| 00845275000641 | K891337 | 000 |
| 00845275000511 | K891337 | 000 |