EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS— 510(k) K101090

Name: FDA 510(k) clearance K101090
Creator: U.S. Food and Drug Administration
Published: 2011-05-20

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K101090 for EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS, Substantially Equivalent on 2011-05-20. Applicant: Medica Corp.. Device class: 2.

Clearance details

Applicant: Medica Corp.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2010-04-19
Decision date: 2011-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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