K954298 is an FDA 510(k) clearance for the VIROTROL IV. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Blackhawk Biosystems, Inc. (San Ramon, US). The FDA issued a Cleared decision on November 1, 1995, 48 days after receiving the submission on September 14, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K954298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1995 |
| Decision Date | November 01, 1995 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |