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FDA 510(k)

ACON STREP A RAPID TEST DEVICE

K-Number: K031784 · 2003-07-14

ApplicantACON Laboratories, Inc.
Decision Date2003-07-14
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACON STREP A RAPID TEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K031784. 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 ACON STREP A RAPID TEST DEVICE?

ACON STREP A RAPID TEST DEVICE is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K031784.

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

ACON STREP A RAPID TEST DEVICE received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031784.

Who is the listed applicant for ACON STREP A RAPID TEST DEVICE?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing ACON Laboratories, Inc. as applicant

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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.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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