The following data is part of a premarket notification filed by Ostex Intl., Inc. with the FDA for Osteomark Ntx Point Of Care Prescription Home Use.
| Device ID | K011052 |
| 510k Number | K011052 |
| Device Name: | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | OSTEX INTL., INC. 2203 AIRPORT WAY SOUTH, SUITE 400 Seattle, WA 98134 |
| Contact | Nancy Js Mallinak |
| Correspondent | Nancy Js Mallinak OSTEX INTL., INC. 2203 AIRPORT WAY SOUTH, SUITE 400 Seattle, WA 98134 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-07-30 |