The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thromboscreen Thromboplastin-ds.
| Device ID | K940082 |
| 510k Number | K940082 |
| Device Name: | THROMBOSCREEN THROMBOPLASTIN-DS |
| Classification | Test, Time, Prothrombin |
| Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. STE. 125 Huntersville, NC 28078 |
| Contact | James Maynard, Ph.d |
| Correspondent | James Maynard, Ph.d PACIFIC HEMOSTASIS 11515 VANSTORY DR. STE. 125 Huntersville, NC 28078 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1995-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000801 | K940082 | 000 |
| 00845275000535 | K940082 | 000 |
| 00845275000528 | K940082 | 000 |