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FDA 510(k)

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)

K-Number: K954257 · 1995-10-20

ApplicantQuidel Corp.
Decision Date1995-10-20
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1995-10-20 under 510(k) number K954257. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)?

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Quidel Corp.. The 510(k) number is K954257.

When did QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) receive FDA 510(k) clearance?

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) received FDA 510(k) clearance on 1995-10-20, under 510(k) number K954257.

Who is the listed applicant for QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)?

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 IN-LINE ONE STEP STREP A TEST (MODIFICATION)?

The FDA product code for QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) is GTZ.

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, Inc.

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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