Cleared Traditional

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS

K963018 · Bio-Rad · Chemistry
Jun 1997
Decision
306d
Days
Class 1
Risk

About This 510(k) Submission

K963018 is an FDA 510(k) clearance for the BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS, a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 4, 1997, 306 days after receiving the submission on August 2, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K963018 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1996
Decision Date June 04, 1997
Days to Decision 306 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEF — Electrophoretic, Protein Fractionation
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1630

Similar Devices — CEF Electrophoretic, Protein Fractionation

All 28
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
K130500 · Sebia · Jul 2013
SPIFE
K972274 · Helena Laboratories · Oct 1997
REP SPE VIS-60/40 KIT
K973316 · Helena Laboratories · Oct 1997
REP 3 FLUR SPE-60 KIT
K964453 · Helena Laboratories · Dec 1996
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029 · Morax · Jul 1996
HYDRAGEL PROTEIN(E) KIT
K951536 · Sebia · Jun 1995