MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

Multi-analyte Controls, All Kinds (assayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Cardioimmune Tl Liquid Assayed Cardiac Marker Control, Levels 1,2 And 3.

Pre-market Notification Details

Device IDK040880
510k NumberK040880
Device Name:MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo,  CA  93012
ContactPenny M Layman
CorrespondentPenny M Layman
MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo,  CA  93012
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-05
Decision Date2004-04-28

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