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FDA 510(k)

QUIDEL QUEST STREP GROUP A TEST

K-Number: K852806 · 1985-07-30

ApplicantQuidel Corp.
Decision Date1985-07-30
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL QUEST STREP GROUP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K852806. 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 QUIDEL QUEST STREP GROUP A TEST?

QUIDEL QUEST STREP GROUP A TEST is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Quidel Corp.. The 510(k) number is K852806.

When did QUIDEL QUEST STREP GROUP A TEST receive FDA 510(k) clearance?

QUIDEL QUEST STREP GROUP A TEST received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852806.

Who is the listed applicant for QUIDEL QUEST STREP GROUP A TEST?

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 QUIDEL QUEST STREP GROUP A TEST?

The FDA product code for QUIDEL QUEST STREP GROUP A TEST is GTZ.

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Related Devices (Code: GTZ)

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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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