510(k) K050305— ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
Substantially EquivalentBioscreen Medical, Inc.
Clearance details
- Applicant
- Bioscreen Medical, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mildred, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.