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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood alcohol kit (excludes hiv testing)
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.
Product CodeOIC
Regulation Number 862.3040
Device Class 2

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