The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Accuclot Drvvt Confirm, Catalog No. A62119.
| Device ID | K000528 |
| 510k Number | K000528 |
| Device Name: | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 |
| Classification | Reagent, Russel Viper Venom |
| 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 | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420487 | K000528 | 000 |