CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II

Multi-analyte Controls, All Kinds (assayed)

CREATIVE LABORATORY PRODUCTS, INC.

The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Low Level Hdl Cholesterol-lipid Control-ii.

Pre-market Notification Details

Device IDK904989
510k NumberK904989
Device Name:CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
ContactGary J Proksch
CorrespondentGary J Proksch
CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-07
Decision Date1991-01-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.