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510(k) K011116

Device
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
Applicant
PASCO LABORATORIES, INC.
510(k) number
K011116
Product code
LTT  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-24
Date received
2001-02-21
Regulation
866.1640
Classification name
Panels, Test, Susceptibility, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LINDA DILLON
Address
12750 W. 42nd Ave. Wheat Ridge CO US 80033 80033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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