THE E TEST, MODIFICATION

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

The following data is part of a premarket notification filed by Ab Biodisk with the FDA for The E Test, Modification.

Pre-market Notification Details

Device IDK913459
510k NumberK913459
Device Name:THE E TEST, MODIFICATION
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK PYRAMIDVAGEN 7 Solna,  SE S-171 36
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK PYRAMIDVAGEN 7 Solna,  SE S-171 36
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-05
Decision Date1991-09-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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03573026253592 K913459 000
03573026256685 K913459 000

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