K945946 is an FDA 510(k) clearance for the OSTEOMARK(R). This device is classified as a Column Chromatography & Color Development, Hydroxyproline (Class I - General Controls, product code JMM).
Submitted by Ostex Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on May 8, 1995, 154 days after receiving the submission on December 5, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1400.
| 510(k) Number | K945946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1994 |
| Decision Date | May 08, 1995 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMM — Column Chromatography & Color Development, Hydroxyproline |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1400 |