Cleared Traditional

SPOTCHEM II LDH TEST

K050790 · Arkray, Inc. · Chemistry
Jun 2005
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K050790 is an FDA 510(k) clearance for the SPOTCHEM II LDH TEST, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 6, 2005, 70 days after receiving the submission on March 28, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K050790 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2005
Decision Date June 06, 2005
Days to Decision 70 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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