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FDA 510(k)

DIRECTIGEN 1-2-3 GROUP A STREP TEST

K-Number: K951542 · 1995-10-20

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1995-10-20
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN 1-2-3 GROUP A STREP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1995-10-20 under 510(k) number K951542. 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 DIRECTIGEN 1-2-3 GROUP A STREP TEST?

DIRECTIGEN 1-2-3 GROUP A STREP TEST is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K951542.

When did DIRECTIGEN 1-2-3 GROUP A STREP TEST receive FDA 510(k) clearance?

DIRECTIGEN 1-2-3 GROUP A STREP TEST received FDA 510(k) clearance on 1995-10-20, under 510(k) number K951542.

Who is the listed applicant for DIRECTIGEN 1-2-3 GROUP A STREP TEST?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECTIGEN 1-2-3 GROUP A STREP TEST?

The FDA product code for DIRECTIGEN 1-2-3 GROUP A STREP TEST 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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