AI-PHOTODIAGNOSTIC
Device Facts
| Record ID | K940004 |
|---|---|
| Device Name | AI-PHOTODIAGNOSTIC |
| Applicant | Pharmarceutical Discovery Corp. |
| Product Code | CIB · Clinical Chemistry |
| Decision Date | Aug 4, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1085 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.
