The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Accuclot Control I.
| Device ID | K981248 |
| 510k Number | K981248 |
| Device Name: | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I |
| Classification | Plasma, Coagulation Control |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert, Ph.d. |
| Correspondent | William R Gilbert, Ph.d. SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-04-29 |
| Summary: | summary |