CJG · Tetrabromo-M-Cresolsulfonphthalein, Albumin
Clinical Chemistry · 21 CFR 862.1035 · Class 2
Overview
| Product Code | CJG |
|---|---|
| Device Name | Tetrabromo-M-Cresolsulfonphthalein, Albumin |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972706 | CLINITEK MICROALBUMIN REAGENT STRIPS | Bayer Corp. | Sep 9, 1997 | SESE |
Top Applicants
- Bayer Corp. — 1 clearance
