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510(k) K212623

Healgen Strep A Rapid Test Strip (Throat Swab) by Healgen Scientific, LLC — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2022
Date Received
August 18, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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