The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Alexin Hs, Models A0969, A1094.
| Device ID | K992711 |
| 510k Number | K992711 |
| Device Name: | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 |
| Classification | Activated Partial Thromboplastin |
| 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 | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-11 |
| Decision Date | 1999-12-06 |
| Summary: | summary |