FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
APTIMA TRICHOMONAS VAGINALIS ASSAY
K Number: DEN110012
·
Decision Apr 19, 2011
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
9
Applicant Total
1
Review Days
6
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Basic Information
- Device Name
- APTIMA TRICHOMONAS VAGINALIS ASSAY
- K Number
- DEN110012
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.3860
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Gen-Probe Incorporated
- Date Received
- April 13, 2011
- Decision Date
- April 19, 2011
- Product Code
- OUY
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | FDA class 2 | Immunology |
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