Cleared Traditional

ENZYME STABILIZING REAGENT (ESR)

K791656 · Electrophoresis Corp. of America · Chemistry
Sep 1979
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K791656 is an FDA 510(k) clearance for the ENZYME STABILIZING REAGENT (ESR), a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 27 days after receiving the submission on August 21, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K791656 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date September 17, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1445

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