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FDA 510(k)

DIRECTIGEN COMBO MENINGITIS TEST

K-Number: K860768 · 1986-05-13

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1986-05-13
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN COMBO MENINGITIS 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 1986-05-13 under 510(k) number K860768. 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 COMBO MENINGITIS TEST?

DIRECTIGEN COMBO MENINGITIS TEST is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K860768.

When did DIRECTIGEN COMBO MENINGITIS TEST receive FDA 510(k) clearance?

DIRECTIGEN COMBO MENINGITIS TEST received FDA 510(k) clearance on 1986-05-13, under 510(k) number K860768.

Who is the listed applicant for DIRECTIGEN COMBO MENINGITIS 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 COMBO MENINGITIS TEST?

The FDA product code for DIRECTIGEN COMBO MENINGITIS TEST is GTZ.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic 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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