VIRAL ACCU-CULSHURE TM

Device, Specimen Collection

MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Viral Accu-culshure Tm.

Pre-market Notification Details

Device IDK903406
510k NumberK903406
Device Name:VIRAL ACCU-CULSHURE TM
ClassificationDevice, Specimen Collection
Applicant MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville,  NY  10570
ContactJoann Hanchrow
CorrespondentJoann Hanchrow
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville,  NY  10570
Product CodeLIO  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-31
Decision Date1990-10-16

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