ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21— 510(k) K913307
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K913307 for ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21, Substantially Equivalent on 1991-10-11. Applicant: Em Diagnostic Systems, Inc..
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CIG
- 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.