VISION CREATINE KINASE— 510(k) K883946

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K883946 for VISION CREATINE KINASE, Substantially Equivalent on 1988-10-13. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-09-19
Decision date: 1988-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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