SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401— 510(k) K905660
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K905660 for SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401, Substantially Equivalent on 1991-01-25. Applicant: Em Diagnostic Systems, Inc..
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CIX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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