HYBRID CAPTURE II CT-ID TEST— 510(k) K990023
Substantially EquivalentDigene Corp.
FDA 510(k) clearance K990023 for HYBRID CAPTURE II CT-ID TEST, Substantially Equivalent on 1999-10-25. 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
- Beltsville, MD, US
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