FDA.reportPublic FDA data

510(k) K920225

Device
Autosceptor Identification System
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K920225
Product code
LRH
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-22
Date received
1992-01-17
Regulation
866.2660
Classification name
Instrument For Auto Reader Of Overnight Microorganism Identification System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL J ARNSBERGE
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 LRH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDBiomerieux Vitek, Inc.1996-08-30
K961042MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANELDade Microscan, Inc.1996-05-30
K926248READERAlamar Biosciences Laboratory, Inc.1994-05-17