The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Thrombomax-hs With Calcium, Model T6540.
| Device ID | K010158 |
| 510k Number | K010158 |
| Device Name: | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 |
| Classification | Reagent, Thromboplastin And Control |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert Ii |
| Correspondent | William R Gilbert Ii SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | GGO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-17 |
| Decision Date | 2001-03-22 |