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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phlebotomy blood collection kit
Regulation Description Impedance phlebograph.
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.
Product CodeOFM
Regulation Number 870.2750
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Medical Action Industries, Inc. 306 I May-12-2021
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