510(k) K030533— ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
Substantially EquivalentCenogenics Corp.
Clearance details
- Applicant
- Cenogenics Corp.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morganville, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.