510(k) K212623

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

K212623 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Strep A Rapid Test Strip (Throat Swab)". The FDA issued a decision of Substantially Equivalent on March 16, 2022. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.