510(k) K860923— EZ DETECT, 5 MINUTE STREP-A COLOR TEST
Substantially EquivalentSelf Care Systems, Inc.
Clearance details
- Applicant
- Self Care Systems, Inc.
- Product code
- Code GTZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.