Cleared Traditional

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

K003093 · Diagnostic Chemicals , Ltd. · Chemistry
Nov 2000
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K003093 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 27, 2000, 55 days after receiving the submission on October 3, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K003093 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2000
Decision Date November 27, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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