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FDA 510(k)

BBL STREP GROUPING KIT

K-Number: K920565 · 1992-03-23

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-03-23
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBL STREP GROUPING KIT 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 1992-03-23 under 510(k) number K920565. 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 BBL STREP GROUPING KIT?

BBL STREP GROUPING KIT is a medical device that received FDA 510(k) clearance on 1992-03-23. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K920565.

When did BBL STREP GROUPING KIT receive FDA 510(k) clearance?

BBL STREP GROUPING KIT received FDA 510(k) clearance on 1992-03-23, under 510(k) number K920565.

Who is the listed applicant for BBL STREP GROUPING KIT?

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 BBL STREP GROUPING KIT?

The FDA product code for BBL STREP GROUPING KIT 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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