CREATINE KINASE TEST (CK) ITEM NUMBER: 65661— 510(k) K884546
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K884546 for CREATINE KINASE TEST (CK) ITEM NUMBER: 65661, Substantially Equivalent on 1989-02-02. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.