OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
Device Facts
| Record ID | K011052 |
|---|---|
| Device Name | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE |
| Applicant | Ostex Intl., Inc. |
| Product Code | JMM · Clinical Chemistry |
| Decision Date | Jul 30, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1400 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.
