Cleared Traditional

MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

K042362 · Diagnostic Chemicals , Ltd. · Chemistry
Dec 2004
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K042362 is an FDA 510(k) clearance for the MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on December 27, 2004, 118 days after receiving the submission on August 31, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K042362 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2004
Decision Date December 27, 2004
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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