HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0

Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl

MORAX

The following data is part of a premarket notification filed by Morax with the FDA for Hydragel Ldl/hdl Chol Direct Kit-p.n. 4005, Hydragel 7 Ldl/hdl Chol Direct Kit-p.n. 4103, Hydragel Ldl/hdl Chol Direct 0.

Pre-market Notification Details

Device IDK990250
510k NumberK990250
Device Name:HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
ClassificationElectrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Applicant MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
ContactBorek Janik
CorrespondentBorek Janik
MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
Product CodeLBT  
Subsequent Product CodeJHO
Subsequent Product CodeLBS
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-26
Decision Date1999-06-18

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