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FDA 510(k)

HYGEIA RAPID STREP A TEST

K-Number: K862133 · 1986-06-25

ApplicantHygeia Sciences
Decision Date1986-06-25
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HYGEIA RAPID STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia Sciences. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K862133. 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 HYGEIA RAPID STREP A TEST?

HYGEIA RAPID STREP A TEST is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Hygeia Sciences. The 510(k) number is K862133.

When did HYGEIA RAPID STREP A TEST receive FDA 510(k) clearance?

HYGEIA RAPID STREP A TEST received FDA 510(k) clearance on 1986-06-25, under 510(k) number K862133.

Who is the listed applicant for HYGEIA RAPID STREP A TEST?

The FDA 510(k) record lists Hygeia Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYGEIA RAPID STREP A TEST?

The FDA product code for HYGEIA RAPID STREP A TEST is GTY.

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Other records listing Hygeia Sciences 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.

K882192HYGEIA URINE PREGNANCY TESTK881064HYGEIA GC TESTK862083HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY

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.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLCK171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel CorporationK123793SOFIA STREP A FIAQuidel CorporationK122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson and Company

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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