ETEST FOR AZTREONAM

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

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

Pre-market Notification Details

Device IDK962794
510k NumberK962794
Device Name:ETEST FOR AZTREONAM
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DALVAGEN 10 Solna,  SE 16956
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DALVAGEN 10 Solna,  SE 16956
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-17
Decision Date1996-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026376765 K962794 000
03573026252403 K962794 000
03573026623586 K962794 000

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