# K963018: Bio-Rad Serum Proteins by Capillary Electrophoresis

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 4, 1997 after 306 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
Longest line of descent: 1 generation back to K802592 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802592: Paragon Serum Protein Electrophoresis, Beckman Instruments, Inc. (1980) Summary page 1.
- K953077: Paragon Cze 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, Inc. (1996). Our OCR of the scanned summary read K853077, FDA’s number for Citrex II (Bio/Data Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Paragon CZE™ 2000 Clinical Capillary Electrophoresis System”.
- K942451: Bio-Rad Clinical Data Management System, Bio-Rad (1994) Summary page 1.

## Indications for use
Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for the separation and measurement of protein fractions in human serum when used with the Bio-Rad BioFocus Capillary Electrophoresis Unit.

Source page: https://510kreport.com/device/K963018
Methodology: https://510kreport.com/methodology