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FDA 510(k)

RAPID COLORIMETRIC DIRECT STREP A TEST

K-Number: K874761 · 1988-02-19

ApplicantNew Horizons Diagnostics Co.
Decision Date1988-02-19
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID COLORIMETRIC DIRECT STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K874761. 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 COLORIMETRIC DIRECT STREP A TEST?

RAPID COLORIMETRIC DIRECT STREP A TEST is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K874761.

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

RAPID COLORIMETRIC DIRECT STREP A TEST received FDA 510(k) clearance on 1988-02-19, under 510(k) number K874761.

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

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for RAPID COLORIMETRIC DIRECT STREP A TEST is GTZ.

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Other records listing New Horizons Diagnostics Co. as applicant

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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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