MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01— 510(k) K010892
Substantially EquivalentDigene Corp.
FDA 510(k) clearance K010892 for MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01, Substantially Equivalent on 2001-09-24. Applicant: Digene Corp.. Device class: 1.
Clearance details
- Applicant
- Digene Corp.
- Product code
- Code LSK
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
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