Cleared Traditional

LDH-INT TEST

K771343 · Hycel, Inc. · Chemistry
Aug 1977
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K771343 is an FDA 510(k) clearance for the 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 August 10, 1977, 21 days after receiving the submission on July 20, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K771343 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1977
Decision Date August 10, 1977
Days to Decision 21 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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