CREATINE KINASE, N-ACETYL-L-CYSTIENE— 510(k) K860669
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K860669 for CREATINE KINASE, N-ACETYL-L-CYSTIENE, Substantially Equivalent on 1986-04-07. Applicant: Em Diagnostic Systems, Inc..
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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