The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thromboscreen Joshua Hemoglobin S Screening Kit.
| Device ID | K872217 |
| 510k Number | K872217 |
| Device Name: | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT |
| 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 | 1987-06-09 |
| Decision Date | 1987-07-31 |