IL TEST CK-MB— 510(k) K952646

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K952646 for IL TEST CK-MB, Substantially Equivalent on 1995-08-04. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1995-06-09
Decision date: 1995-08-04
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.