CPK ULTRAZYME PLUS— 510(k) K770694

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K770694 for CPK ULTRAZYME PLUS, Substantially Equivalent on 1977-07-01. Applicant: Harleco Diagnostics. Device class: 2.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1977-04-15
Decision date: 1977-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.