FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K Number: K081522
·
Decision Dec 5, 2008
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
1
Review Days
189
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Basic Information
- Device Name
- BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
- K Number
- K081522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio Nuclear Diagnostics, Inc.
- Date Received
- May 30, 2008
- Decision Date
- December 5, 2008
- Product Code
- HHT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
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