Cleared Traditional

LACTATE DEHYDROGENASE (LDH) REAGENT SET

K860349 · Sterling Diagnostics, Inc. · Chemistry
Feb 1986
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K860349 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE (LDH) REAGENT SET, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 28, 1986, 29 days after receiving the submission on January 30, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K860349 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1986
Decision Date February 28, 1986
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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