Cleared Traditional

CARDIO REP LD

K940224 · Helena Laboratories · Chemistry
Aug 1994
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K940224 is an FDA 510(k) clearance for the CARDIO REP LD, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 17, 1994, 211 days after receiving the submission on January 18, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K940224 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1994
Decision Date August 17, 1994
Days to Decision 211 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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