CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

Enzyme Controls (assayed And Unassayed)

MEDICAL ANALYSIS SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK992430
510k NumberK992430
Device Name:CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo,  CA  93012 -8058
ContactScot D Kinghorn
CorrespondentScot D Kinghorn
MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo,  CA  93012 -8058
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-21
Decision Date1999-08-30

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