510(k) K904102— REFLOTRON CREATINE KINASE TEST TABS
Substantially EquivalentBoehringer Mannheim Corp.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code CGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.