Cleared Traditional

IQ LDH

K894578 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Toxicology
Oct 1989
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K894578 is an FDA 510(k) clearance for the IQ LDH, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 17, 1989, 85 days after receiving the submission on July 24, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K894578 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1989
Decision Date October 17, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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