Cleared Traditional

LACTATE DEHYDROGENASE (LDH-L)

K880630 · Tech-Co, Inc. · Chemistry
Mar 1988
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K880630 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE (LDH-L), a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on March 16, 1988, 29 days after receiving the submission on February 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K880630 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1988
Decision Date March 16, 1988
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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