K-number	K212623
Device name	Healgen Strep A Rapid Test Strip (Throat Swab)
Applicant	Healgen Scientific,, LLC
Product code	GTY
Device class	Class I
Decision date	Mar 16, 2022
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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Healgen Strep A Rapid Test Strip (Throat Swab)

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