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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 the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2022-03-16 under 510(k) 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. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K212623.

When did Healgen Strep A Rapid Test Strip (Throat Swab) receive FDA 510(k) clearance?

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

Who is the listed applicant for Healgen Strep A Rapid Test Strip (Throat Swab)?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Healgen Scientific,, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260095Heal-Check Rapid COVID-19 Antigen Self-TestK253705Healgen® Accurate Oral Fluid Drug TestK252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestK253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardK251800Healgen® URS Test StripsK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

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Related Devices (Code: GTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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