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FDA 510(k)

QUICKVUE DIPSTICK STREP A

K-Number: K011097 · 2001-05-08

ApplicantQuidel Corp.
Decision Date2001-05-08
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE DIPSTICK STREP A is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2001-05-08 under 510(k) number K011097. 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 QUICKVUE DIPSTICK STREP A?

QUICKVUE DIPSTICK STREP A is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Quidel Corp.. The 510(k) number is K011097.

When did QUICKVUE DIPSTICK STREP A receive FDA 510(k) clearance?

QUICKVUE DIPSTICK STREP A received FDA 510(k) clearance on 2001-05-08, under 510(k) number K011097.

Who is the listed applicant for QUICKVUE DIPSTICK STREP A?

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

What is the FDA product code for QUICKVUE DIPSTICK STREP A?

The FDA product code for QUICKVUE DIPSTICK STREP A is GTY.

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Other records listing Quidel Corp. as applicant

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K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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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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