Seminal Fluid Collection Kit
The Seminal Fluid Collection Kit (product code OKW) is a Class 2 convenience kit regulated under 21 CFR 884.5300 in the Obstetrics/Gynecology specialty (OB). Intended to facilitate the collection of seminal fluid specimens, the kit is under enforcement discretion per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) premarket notification if all guidance criteria are met. The device is not an implant and is not life-sustaining.
Research product code OKW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OKW
- Device Class
- FDA class 2
- Regulation Number
- 884.5300
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.