The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thromboscreen 200.
| Device ID | K991321 |
| 510k Number | K991321 |
| Device Name: | PACIFIC HEMOSTASIS THROMBOSCREEN 200 |
| Classification | Instrument, Coagulation |
| Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Contact | Larry Kopyta |
| Correspondent | Larry Kopyta PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-06-21 |
| Summary: | summary |