Cleared Traditional

CLINISTAT LDH REAGENT TEST

K895138 · Heraeus Kulzer, Inc. · Chemistry
Oct 1989
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K895138 is an FDA 510(k) clearance for the CLINISTAT LDH REAGENT TEST, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on October 19, 1989, 64 days after receiving the submission on August 16, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K895138 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1989
Decision Date October 19, 1989
Days to Decision 64 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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