Submission Details
| 510(k) Number | K000528 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 2000 |
| Decision Date | April 07, 2000 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Apr 2000
Decision
50d
Days
Class 1
Risk
About This 510(k) Submission
K000528 is an FDA 510(k) clearance for the ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119, a Reagent, Russel Viper Venom (Class I — General Controls, product code GIR), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 7, 2000, 50 days after receiving the submission on February 17, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.
Device Classification
| Product Code | GIR — Reagent, Russel Viper Venom |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.8950 |
Manufacturer
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