ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
Device Facts
| Record ID | K853049 |
|---|---|
| Device Name | ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE |
| Applicant | Simmler, Inc. |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Aug 2, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
