CREATINE KINASE REAGENT— 510(k) K980012
Substantially EquivalentAc Biochemicals, Inc.
FDA 510(k) clearance K980012 for CREATINE KINASE REAGENT, Substantially Equivalent on 1998-02-25. Applicant: Ac Biochemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Ac Biochemicals, Inc.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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