K991917 is an FDA 510(k) clearance for the OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET. This device is classified as a Urinalysis Controls (assayed And Unassayed) (Class I - General Controls, product code JJW).
Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 12, 1999, 35 days after receiving the submission on June 7, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K991917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1999 |
| Decision Date | July 12, 1999 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJW — Urinalysis Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |