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FDA 510(k)

Healgen Strep A Rapid Test Strip (Throat Swab)

K-Number: K212623 · 2022-03-16

ApplicantHealgen Scientific,, LLC
Decision Date2022-03-16
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Healgen Strep A Rapid Test Strip (Throat Swab) is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2022-03-16 under approval number K212623. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen Strep A Rapid Test Strip (Throat Swab)?

Healgen Strep A Rapid Test Strip (Throat Swab) is a medical device that received FDA 510(k) clearance on 2022-03-16. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K212623.

When was Healgen Strep A Rapid Test Strip (Throat Swab) approved by the FDA?

Healgen Strep A Rapid Test Strip (Throat Swab) received FDA 510(k) clearance on 2022-03-16, under approval number K212623.

What company makes Healgen Strep A Rapid Test Strip (Throat Swab)?

Healgen Strep A Rapid Test Strip (Throat Swab) is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab)?

The FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab) is GTY.

Other Devices by Healgen Scientific,, LLC

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card K231045Healgen URS Test Strips K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

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Related Devices (Code: GTY)

K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc. K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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