Cleared Traditional

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

K042448 · General Atomics · Chemistry
Oct 2004
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K042448 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by General Atomics (San Diego, US). The FDA issued a Cleared decision on October 29, 2004, 50 days after receiving the submission on September 9, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K042448 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2004
Decision Date October 29, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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