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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, nitrogen dioxide, exempt
Regulation Description Nitrogen dioxide analyzer.
Definition This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePUG
Regulation Number 868.2385
Device Class 2

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