Cleared Traditional

HYCEL LDH-INT TEST

K782176 · Hycel, Inc. · Chemistry
Jan 1979
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K782176 is an FDA 510(k) clearance for the HYCEL LDH-INT TEST, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979, 29 days after receiving the submission on December 28, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K782176 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1978
Decision Date January 26, 1979
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFH — Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1440

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