510(k) K850079— NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
Substantially EquivalentBioclinical Systems, Inc.
Clearance details
- Applicant
- Bioclinical Systems, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St.Louis, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.