ETEST FOR QUINUPRISTIN/DALFOPRISTIN

Discs, Elution

AB BIODISK

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

Pre-market Notification Details

Device IDK992993
510k NumberK992993
Device Name:ETEST FOR QUINUPRISTIN/DALFOPRISTIN
ClassificationDiscs, Elution
Applicant AB BIODISK DALVAGEN 10 Solna,  SE 16956
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DALVAGEN 10 Solna,  SE 16956
Product CodeLTX  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-07
Decision Date1999-11-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026253479 K992993 000
03573026378530 K992993 000

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