Cleared Traditional

ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

K023840 · Bayer Diagnostics Corp. · Chemistry
Jan 2003
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K023840 is an FDA 510(k) clearance for the ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 7, 2003, 50 days after receiving the submission on November 18, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K023840 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2002
Decision Date January 07, 2003
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKB — Acid Phosphatase, Naphthyl Phosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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