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510(k) K890057

Device
SENSITITRE AUTO ID PLATE AP80
Applicant
RADIOMETER AMERICA, INC.
510(k) number
K890057
Product code
LQM  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-09
Date received
1989-01-06
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
L VEDAA
Address
811 Sharon Dr. Westlake OH US 44145 44145

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
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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