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510(k) K851528

Device
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
Applicant
PASCO LABORATORIES, INC.
510(k) number
K851528
Product code
LQM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-15
Date received
1985-04-18
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
LINDA K DILLON
Address
12750 W. 42nd Ave. Wheat Ridge CO US 80033 80033

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
K862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELAmerican Micro Scan1986-09-11

Legacy Summary#

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FDA Review#

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