APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT

Turbidimetric Method, Lipoproteins

RANDOX LABORATORIES, LTD.

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

Pre-market Notification Details

Device IDK950382
510k NumberK950382
Device Name:APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
ClassificationTurbidimetric Method, Lipoproteins
Applicant RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim,  IE Bt29 4qy
ContactJohn Lamont
CorrespondentJohn Lamont
RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim,  IE Bt29 4qy
Product CodeJHN  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-31
Decision Date1995-09-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055273204452 K950382 000
05055273204391 K950382 000
05055273204360 K950382 000
05055273204339 K950382 000
05051700016889 K950382 000

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