MAS PAR TDM

Drug Mixture Control Materials

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Par Tdm.

Pre-market Notification Details

Device IDK032826
510k NumberK032826
Device Name:MAS PAR TDM
ClassificationDrug Mixture Control Materials
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 CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-10
Decision Date2003-10-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883011694 K032826 000
00884883002432 K032826 000
00884883002425 K032826 000
00884883002418 K032826 000

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