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PQD — Blood Specimen Collection Convenience Kit (Excludes Hiv) Class II

FDA Device Classification

FDA product code PQD covers "Blood Specimen Collection Convenience Kit (Excludes Hiv)", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
PQD
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
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.

FDA data resources