Cleared Traditional

DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX

K073488 · Diazyme Laboratories · Chemistry
Mar 2008
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K073488 is an FDA 510(k) clearance for the DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on March 7, 2008, 137 days after receiving the submission on October 22, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K073488 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2007
Decision Date March 07, 2008
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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