CK-1 ULTRAZYME PLUS— 510(k) K771389

Substantially Equivalent

Harleco

FDA 510(k) clearance K771389 for CK-1 ULTRAZYME PLUS, Substantially Equivalent on 1977-09-02. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1977-07-27
Decision date: 1977-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.