QUICKSTRIP ONE STEP OPIATES TEST

Enzyme Immunoassay, Opiates

SYNTRON BIORESEARCH, INC.

The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quickstrip One Step Opiates Test.

Pre-market Notification Details

Device IDK993490
510k NumberK993490
Device Name:QUICKSTRIP ONE STEP OPIATES TEST
ClassificationEnzyme Immunoassay, Opiates
Applicant SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley,  CA  93065
ContactCleve W Laird
CorrespondentJames M Barquest
CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento,  CA  94234 -7320
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-10-15
Decision Date1999-10-29
Summary:summary

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