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510(k) K925915

Device
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
Applicant
BIOMERIEUX VITEK, INC.
510(k) number
K925915
Product code
LQM  
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-23
Date received
1992-11-23
Regulation
866.2660
Classification name
Gram Negative Identification Panel
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERYL WINTERS-HEARD
Address
595 Anglum Dr. Hazelwood MO US 63042 63042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923313ROCHE OXI/FERM IIRoche Diagnostic Systems, Inc.1993-04-05
K912897SCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1991-10-28
K911429VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDVitek Systems, Inc.1991-06-24
K890057SENSITITRE AUTO ID PLATE AP80Radiometer America, Inc.1989-06-09
K862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELAmerican Micro Scan1986-09-11
K851528PASCO GRAM NEGATIVE IDENTIFICATION SYSTEMPasco Laboratories, Inc.1985-07-15

Legacy Summary#

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FDA Review#

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