Cleared Traditional

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD

K921455 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Apr 1992
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K921455 is an FDA 510(k) clearance for the ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 29, 1992, 33 days after receiving the submission on March 27, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K921455 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1992
Decision Date April 29, 1992
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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