CK-MB (NAC-ACT)— 510(k) K951223

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K951223 for CK-MB (NAC-ACT), Substantially Equivalent on 1995-12-26. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1995-03-20
Decision date: 1995-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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