MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL

Urinalysis 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 Mas Ua Control, Dade Ua Control- Liquid Assayed Urinalysis Control.

Pre-market Notification Details

Device IDK021155
510k NumberK021155
Device Name:MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
ClassificationUrinalysis Controls (assayed And Unassayed)
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 CodeJJW  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-10
Decision Date2002-04-29

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