Cytology Kit
The Cytology Kit (product code OKY) is a Class 2 convenience kit regulated under 21 CFR 884.4530 in the Obstetrics/Gynecology specialty (OB), used for collecting and processing cytological specimens. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this kit type is under enforcement discretion and does not require a 510(k) premarket notification if all guidance criteria are satisfied. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKY
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.