OHZ — Urine Transport Kit (Excludes Hiv Testing) Class I
FDA product code OHZ covers "Urine Transport Kit (Excludes Hiv Testing)", a Class I medical device regulated under 21 CFR 864.3250. Submissions are reviewed by the Pathology panel.
Classification Details
- Product Code
- OHZ
- Device Class
- Class I
- Regulation Number
- 864.3250
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Pathology
- 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 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.