CPK ISOENZYME CONTROL— 510(k) K791299
Substantially EquivalentElectrophoresis Corp. of America
FDA 510(k) clearance K791299 for CPK ISOENZYME CONTROL, Substantially Equivalent on 1979-08-16. Applicant: Electrophoresis Corp. of America. Device class: 1.
Clearance details
- Applicant
- Electrophoresis Corp. of America
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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