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