ULTRAZYME PLUS CK-1— 510(k) K780100

Substantially Equivalent

Harleco

FDA 510(k) clearance K780100 for ULTRAZYME PLUS CK-1, Substantially Equivalent on 1978-03-09. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1978-01-20
Decision date: 1978-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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