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510(k) K920131

Device
CLARITHROMYCIN 15MCG SENSI DISC
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K920131
Product code
JTM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-02-06
Date received
1992-01-10
Regulation
866.2120
Classification name
Anaerobic Box Glove
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL ARNSBERGER
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800430OXIDE ANAEROBIC SYSTEMOxoid U.S.A., Inc.1980-04-02

Legacy Summary#

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FDA Review#

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