OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3

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 Opiates 2000 Liquid Opiates Drugs Of Abuse Control Levels 2 And 3.

Pre-market Notification Details

Device IDK982024
510k NumberK982024
Device Name:OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
ClassificationDrug Mixture Control Materials
Applicant MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo,  CA  93012 -8058
ContactScot Kinghorn
CorrespondentScot Kinghorn
MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo,  CA  93012 -8058
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-09
Decision Date1998-06-29

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