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FDA 510(k)

ACON STREP A RAPID TEST STRIP

K-Number: K010582 · 2001-05-07

ApplicantAcon Laboratories Co.
Decision Date2001-05-07
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACON STREP A RAPID TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Acon Laboratories Co.. It received FDA 510(k) clearance on 2001-05-07 under 510(k) number K010582. 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 STRIP?

ACON STREP A RAPID TEST STRIP is a medical device that received FDA 510(k) clearance on 2001-05-07. The listed applicant is Acon Laboratories Co.. The 510(k) number is K010582.

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

ACON STREP A RAPID TEST STRIP received FDA 510(k) clearance on 2001-05-07, under 510(k) number K010582.

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

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

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

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

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Other records listing Acon Laboratories Co. 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.

K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEMK061559ACON URINALYSIS REAGENT STRIPSK023766ACON STREP A TWIST TEST DEVICEK020313ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICEK980736ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

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

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

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