MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
FDA 510(k) clearance K010891 · decided 2001-09-25
Clearance details
- K-number
- K010891
- Device name
- MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
- Applicant
- Digene Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-26
- Decision date
- 2001-09-25
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- LSK
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.