510(k) K974059— ONE STEP MIDSTREAM HCG PREGNANCY TEST
Substantially EquivalentInternational Newtech Development, Inc.
Clearance details
- Applicant
- International Newtech Development, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Delta, B.C., CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.