The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thrombo Screeen Fibrin Degradation Product Kit.
| Device ID | K852512 |
| 510k Number | K852512 |
| Device Name: | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT |
| Classification | Fibrin Split Products |
| 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 | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000900 | K852512 | 000 |
| 00845275000894 | K852512 | 000 |
| 00845275000887 | K852512 | 000 |
| 00845275000870 | K852512 | 000 |
| 00845275000863 | K852512 | 000 |