OSTEOMARK
Column Chromatography & Color Development, Hydroxyproline
OSTEX INTL., INC.
The following data is part of a premarket notification filed by Ostex Intl., Inc. with the FDA for Osteomark.
Pre-market Notification Details
| Device ID | K980518 |
| 510k Number | K980518 |
| Device Name: | OSTEOMARK |
| 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 | 1998-01-16 |
| Decision Date | 1998-03-06 |
| Summary: | summary |
Trademark Results [OSTEOMARK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOMARK 74801494 1819369 Live/Registered |
ALERE NORTH AMERICA, LLC 1990-09-24 |
 OSTEOMARK 74099485 1819553 Live/Registered |
ALERE NORTH AMERICA, LLC 1990-09-24 |
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