LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

Multi-analyte Controls, All Kinds (assayed)

RANDOX LABORATORIES LIMITED

The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Liquid Assayed Chemistry Control Premium Plus Level 1,2 And Level 3..

Pre-market Notification Details

Device IDK140971
510k NumberK140971
Device Name:LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim,  GB Bt29 4qy
ContactPauline Armstrong
CorrespondentPauline Armstrong
RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim,  GB Bt29 4qy
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-16
Decision Date2014-12-08
Summary:summary

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