The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Thrombomax With Calcium.
| Device ID | K972796 |
| 510k Number | K972796 |
| Device Name: | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM |
| Classification | Test, Time, Prothrombin |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-10-10 |
| Summary: | summary |