510(k) K961965— SURE CHECK PREGNANCY TEST
Substantially EquivalentChembio Diagnostic Systems, Inc.
Clearance details
- Applicant
- Chembio Diagnostic Systems, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck,, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.