Cleared Traditional

EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

K101090 · Medica Corp. · Chemistry
May 2011
Decision
396d
Days
Class 2
Risk

About This 510(k) Submission

K101090 is an FDA 510(k) clearance for the EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on May 20, 2011, 396 days after receiving the submission on April 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K101090 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2010
Decision Date May 20, 2011
Days to Decision 396 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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