REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
Device Facts
| Record ID | K893211 |
|---|---|
| Device Name | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 |
| Applicant | Helena Laboratories |
| Product Code | CEF · Clinical Chemistry |
| Decision Date | Jun 19, 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.
