510(k) K990023— HYBRID CAPTURE II CT-ID TEST
Substantially EquivalentDigene Corp.
Clearance details
- Applicant
- Digene Corp.
- Product code
- Code LSK
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beltsville, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.