PYRILINKS POLYCLONAL ASSAY KIT
Device Facts
| Record ID | K952026 |
|---|---|
| Device Name | PYRILINKS POLYCLONAL ASSAY KIT |
| Applicant | Metra Biosystems, Inc. |
| Product Code | JMM · Clinical Chemistry |
| Decision Date | Nov 3, 1995 |
| 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.
