The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Accuclot La Control.
| Device ID | K020109 |
| 510k Number | K020109 |
| Device Name: | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL |
| Classification | Control, Plasma, Abnormal |
| 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 | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-11 |
| Decision Date | 2002-02-06 |
| Summary: | summary |