Cleared Traditional

DRI-STAT ACID PHOSPHATASE REAGENT

K053612 · Beckman Coulter, Inc. · Chemistry
Apr 2006
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K053612 is an FDA 510(k) clearance for the DRI-STAT ACID PHOSPHATASE REAGENT, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 26, 2006, 120 days after receiving the submission on December 27, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K053612 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2005
Decision Date April 26, 2006
Days to Decision 120 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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