PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA— 510(k) K915200
Substantially EquivalentBecton Dickinson Advanced Diagnostics
FDA 510(k) clearance K915200 for PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA, Substantially Equivalent on 1991-12-16. Applicant: Becton Dickinson Advanced Diagnostics.
Clearance details
- Applicant
- Becton Dickinson Advanced Diagnostics
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cockeysville, MD, US
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.