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510(k) K862642

Device
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
Applicant
AMERICAN MICRO SCAN
510(k) number
K862642
Product code
LQM  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-11
Date received
1986-07-11
Regulation
866.2660
Classification name
Gram Negative Identification Panel
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORRAINE WEAVER
Address
1584 Enterprise Blvd. West Sacramento CA US 95691 95691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K925915VITEK RAPID CALL-GRAM NEGATIV IDENT CARDBiomerieux Vitek, Inc.1993-03-23
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
K851528PASCO GRAM NEGATIVE IDENTIFICATION SYSTEMPasco Laboratories, Inc.1985-07-15

Legacy Summary#

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FDA Review#

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