EASY LYTE CALCIUM ANALYZER— 510(k) K943091

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K943091 for EASY LYTE CALCIUM ANALYZER, Substantially Equivalent on 1995-01-17. Applicant: Medica Corp.. Device class: 2.

Clearance details

Applicant: Medica Corp.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1994-06-28
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.