K050961 is an FDA 510(k) clearance for the RNA1C CONTROL FOR NYCOCARD HBA1C. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX).
Submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on May 13, 2005, 25 days after receiving the submission on April 18, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K050961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2005 |
| Decision Date | May 13, 2005 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |