REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
Device Facts
| Record ID | K900251 |
|---|---|
| Device Name | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 |
| Applicant | Helena Laboratories |
| Product Code | CEF · Clinical Chemistry |
| Decision Date | Feb 26, 1990 |
| 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.
