The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thrombo Screen Sickle Cell Assay Set.
| Device ID | K854079 |
| 510k Number | K854079 |
| Device Name: | THROMBO SCREEN SICKLE CELL ASSAY SET |
| Classification | Test, Sickle Cell |
| Applicant | PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1985-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000757 | K854079 | 000 |
| 00845275000740 | K854079 | 000 |
| 00845275000733 | K854079 | 000 |