AMIKACIN

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Amikacin.

Pre-market Notification Details

Device IDK970210
510k NumberK970210
Device Name:AMIKACIN
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-21
Decision Date1997-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026376567 K970210 000
03573026252342 K970210 000
03573026619633 K970210 000

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