The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Thromboplastin With Calcium.
| Device ID | K902096 |
| 510k Number | K902096 |
| Device Name: | THROMBOPLASTIN WITH CALCIUM |
| Classification | Test, Time, Prothrombin |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Daniel E Lawson,phd |
| Correspondent | Daniel E Lawson,phd SIGMA CHEMICAL CO. 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 | 1990-05-08 |
| Decision Date | 1990-07-03 |