The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for Drx Ntx Or, Osteomark Ntx Direct Response.
| Device ID | K984530 |
| 510k Number | K984530 |
| Device Name: | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE |
| Classification | Enzymatic Method, Creatinine |
| Applicant | METRIKA, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati METRIKA, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-08-10 |
| Summary: | summary |