WORTHINGTON FLOZYME* CPK (340NM)— 510(k) K800028

Substantially Equivalent

Worthington Diagnostic Systems

FDA 510(k) clearance K800028 for WORTHINGTON FLOZYME* CPK (340NM), Substantially Equivalent on 1980-01-21. Applicant: Worthington Diagnostic Systems. Device class: 2.

Clearance details

Applicant
Worthington Diagnostic Systems
Product code
Code JHS
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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