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510(k) K031364

Device
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
Applicant
Medical Analysis Systems, Inc.
510(k) number
K031364
Product code
JJY
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-30
Date received
2003-04-30
Regulation
862.1660
Classification name
Multi-Analyte Controls, All Kinds (Assayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
PENNY M LAYMAN
Address
5300 Adolfo Rd. Camarillo CA US 93012 93012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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