MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01— 510(k) K010891
Substantially EquivalentDigene Corp.
FDA 510(k) clearance K010891 for MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01, Substantially Equivalent on 2001-09-25. Applicant: Digene Corp..
Clearance details
- Applicant
- Digene Corp.
- Product code
- Code LSK
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.