HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)— 510(k) K123703
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K123703 for HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE), Substantially Equivalent on 2013-04-10. Applicant: Healgen Scientific,, LLC.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.