The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thromboplastin D.
| Device ID | K994100 |
| 510k Number | K994100 |
| Device Name: | PACIFIC HEMOSTASIS THROMBOPLASTIN D |
| Classification | Test, Time, Prothrombin |
| Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Contact | Laura A Worfolk |
| Correspondent | Laura A Worfolk PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 2000-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000795 | K994100 | 000 |
| 00845275000542 | K994100 | 000 |