PWP — Blood Borne Pathogen Response Kit Class I
FDA product code PWP covers "Blood Borne Pathogen Response Kit", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- PWP
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.