KULTSURE STARSWAB(M240), MODIFICATION

Culture Media, Non-propagating Transport

NCS DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Kultsure Starswab(m240), Modification.

Pre-market Notification Details

Device IDK943499
510k NumberK943499
Device Name:KULTSURE STARSWAB(M240), MODIFICATION
ClassificationCulture Media, Non-propagating Transport
Applicant NCS DIAGNOSTICS, INC. 50 STEINWAY BLVD. Etobicoke, Ontario,  CA M9w 6y3
ContactMehdi Karamchi
CorrespondentMehdi Karamchi
NCS DIAGNOSTICS, INC. 50 STEINWAY BLVD. Etobicoke, Ontario,  CA M9w 6y3
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-13
Decision Date1994-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838066931 K943499 000
00848838066924 K943499 000
00848838066917 K943499 000
00848838066900 K943499 000
00848838066894 K943499 000
00848838066887 K943499 000
00848838066856 K943499 000

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