EASYRA MG REAGENT, MODEL 10220— 510(k) K092737

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K092737 for EASYRA MG REAGENT, MODEL 10220, Substantially Equivalent on 2009-11-17. Applicant: Medica Corp.. Device class: 1.

Clearance details

Applicant: Medica Corp.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 2009-09-08
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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