CREATINE KINASE METHOD— 510(k) K941584
Substantially EquivalentDupont Medical Products
FDA 510(k) clearance K941584 for CREATINE KINASE METHOD, Substantially Equivalent on 1994-07-06. Applicant: Dupont Medical Products. Device class: 2.
Clearance details
- Applicant
- Dupont Medical Products
- 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
- Wilmington, DE, US
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