Cleared Traditional

CARESIDE LDH

K020484 · Careside, Inc. · Chemistry
Jul 2002
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K020484 is an FDA 510(k) clearance for the CARESIDE LDH, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 3, 2002, 140 days after receiving the submission on February 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K020484 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date July 03, 2002
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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