RAI-TROL ELEVATED LIPIDS CONTROL

Multi-analyte Controls, All Kinds (assayed)

REAGENTS APPLICATIONS, INC.

The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Rai-trol Elevated Lipids Control.

Pre-market Notification Details

Device IDK915191
510k NumberK915191
Device Name:RAI-TROL ELEVATED LIPIDS CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
ContactPeacock, Jr.
CorrespondentPeacock, Jr.
REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-19
Decision Date1991-12-18

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