Cleared Traditional

ECA PREP

K781117 · Electrophoresis Corp. of America · Chemistry
Aug 1978
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K781117 is an FDA 510(k) clearance for the ECA PREP, a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978, 38 days after receiving the submission on July 3, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K781117 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1978
Decision Date August 10, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018 · Bio-Rad · Jun 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