# K973316: Rep Spe Vis-60/40 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 1, 1997 after 28 days
- Product code: CEF (Electrophoretic, Protein Fractionation)
- Device class: 1
- Regulation: 21 CFR 862.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
These kits are intended for separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer. This test can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias and genetic deficiencies.

Source page: https://510kreport.com/device/K973316
Methodology: https://510kreport.com/methodology