TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
Device Facts
| Record ID | K870958 |
|---|---|
| Device Name | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 |
| Applicant | Helena Laboratories |
| Product Code | CEF · Clinical Chemistry |
| Decision Date | Apr 29, 1987 |
| 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.
