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FDA 510(k)

QUIDEL GROUP A STREP TEST

K-Number: K883999 · 1988-10-12

ApplicantQuidel Corp.
Decision Date1988-10-12
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL GROUP A STREP 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 1988-10-12 under 510(k) number K883999. 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 GROUP A STREP TEST?

QUIDEL GROUP A STREP TEST is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Quidel Corp.. The 510(k) number is K883999.

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

QUIDEL GROUP A STREP TEST received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883999.

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

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

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Other records listing Quidel Corp. as applicant

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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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