ORTHO VIRAL TRANSPORT

Culture Media, Non-propagating Transport

ORTHO DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Viral Transport.

Pre-market Notification Details

Device IDK853500
510k NumberK853500
Device Name:ORTHO VIRAL TRANSPORT
ClassificationCulture Media, Non-propagating Transport
Applicant ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria,  CA  93013
ContactLarry D Mcclain
CorrespondentLarry D Mcclain
ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria,  CA  93013
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-20
Decision Date1985-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101410 K853500 000

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