CEDIA DAU CONTROLS

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 Cedia Dau Controls.

Pre-market Notification Details

Device IDK934650
510k NumberK934650
Device Name:CEDIA DAU CONTROLS
ClassificationDrug Mixture Control Materials
Applicant MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
ContactDonna L Anderson
CorrespondentDonna L Anderson
MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo,  CA  93012
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-29
Decision Date1994-04-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883004856 K934650 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.