TOTAL PROTEIN PROCEDURE
Device Facts
| Record ID | K861663 |
|---|---|
| Device Name | TOTAL PROTEIN PROCEDURE |
| Applicant | Data Medical Associates, Inc. |
| Product Code | CEK · Clinical Chemistry |
| Decision Date | Jun 13, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1635 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
