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510(k) K993377

Device
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
510(k) number
K993377
Product code
NAQ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-01-13
Date received
1999-09-28
Regulation
862.1175
Classification name
Lipoprotein, High Density, Hdl, Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARGO ENRIGHT
Address
7736 Zionsville Rd. Indianapolis IN US 46268 46268

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NAQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060617PTS PANELS HDL CHOLESTEROL TEST STRIPSPolymer Technology Systems, Inc.2006-04-05

Legacy Summary#

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FDA Review#

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