EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816— 510(k) K990971

Name: FDA 510(k) clearance K990971
Creator: U.S. Food and Drug Administration
Published: 1999-04-27

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K990971 for EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816, Substantially Equivalent on 1999-04-27. Applicant: Medica Corp.. Device class: 1.

Clearance details

Applicant: Medica Corp.
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1999-03-23
Decision date: 1999-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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