510(k) K030620

Device
PASCO MIC AND MIC/ID PANELS
Applicant
PASCO LABORATORIES, INC.
510(k) number
K030620
Product code
LTT  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-14
Date received
2003-02-27
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 K DILLON
Address
12750 W. 42nd Ave. Wheat Ridge CO US 80033 80033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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