K940490 is an FDA 510(k) clearance for the DV TEST AND DVV CONFIRM. This device is classified as a Reagent, Russel Viper Venom (Class I - General Controls, product code GIR).
Submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on April 5, 1995, 426 days after receiving the submission on February 3, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8950.
| 510(k) Number | K940490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1994 |
| Decision Date | April 05, 1995 |
| Days to Decision | 426 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GIR — Reagent, Russel Viper Venom |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8950 |