RANDOX AMIKACIN

Radioimmunoassay, Amikacin

RANDOX LABORATORIES, LTD.

The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Amikacin.

Pre-market Notification Details

Device IDK033884
510k NumberK033884
Device Name:RANDOX AMIKACIN
ClassificationRadioimmunoassay, Amikacin
Applicant RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim,  GB Bt29 4qy
ContactPauline Armstrong
CorrespondentPauline Armstrong
RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim,  GB Bt29 4qy
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-15
Decision Date2004-06-09

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