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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device allergen and vaccine delivery needles
Regulation Description Hypodermic single lumen needle.
Definition An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.
Product CodeSCL
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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