OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE— 510(k) K011052
Substantially EquivalentOstex Intl., Inc.
FDA 510(k) clearance K011052 for OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE, Substantially Equivalent on 2001-07-30. Applicant: Ostex Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Ostex Intl., Inc.
- Product code
- Code JMM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1400
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
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