MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01— 510(k) K010893
Substantially EquivalentDigene Corp.
FDA 510(k) clearance K010893 for MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01, Substantially Equivalent on 2001-09-24. Applicant: Digene Corp..
Clearance details
- Applicant
- Digene Corp.
- Product code
- Code LSL
- 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.