The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Accuclot Thrombin Time Reagent Model A8713/a4589.
| Device ID | K982209 |
| 510k Number | K982209 |
| Device Name: | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 |
| Classification | Test, Thrombin Time |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Willian R Gilbert |
| Correspondent | Willian R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-23 |
| Decision Date | 1998-10-15 |
| Summary: | summary |