ABBOTT QUICKSTART CHOLESTEROL TEST— 510(k) K913565
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K913565 for ABBOTT QUICKSTART CHOLESTEROL TEST, Substantially Equivalent on 1991-12-18. Applicant: Em Diagnostic Systems, Inc..
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CHH
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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