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FDA 510(k)

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST

K-Number: K852841 · 1985-07-24

ApplicantSmithkline Diagnostics, Inc.
Decision Date1985-07-24
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K852841. 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 RAPID DIRECT STREP A LATEX AGGLUTINATION TEST?

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K852841.

When did RAPID DIRECT STREP A LATEX AGGLUTINATION TEST receive FDA 510(k) clearance?

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 1985-07-24, under 510(k) number K852841.

Who is the listed applicant for RAPID DIRECT STREP A LATEX AGGLUTINATION TEST?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID DIRECT STREP A LATEX AGGLUTINATION TEST?

The FDA product code for RAPID DIRECT STREP A LATEX AGGLUTINATION 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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