REP TM SPE (PONCEAU S) PROCEDURES
Device Facts
| Record ID | K894585 |
|---|---|
| Device Name | REP TM SPE (PONCEAU S) PROCEDURES |
| Applicant | Helena Laboratories |
| Product Code | CEF · Clinical Chemistry |
| Decision Date | Sep 13, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1630 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.
