510(k) K905660— SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
Substantially EquivalentEm 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.