The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for Osteomark Ntx Poc.
| Device ID | K992997 |
| 510k Number | K992997 |
| Device Name: | OSTEOMARK NTX POC |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-11-09 |