NIACIN CONTROL DISKS

Discs, Strips And Reagents, Microorganism Differentiation

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Niacin Control Disks.

Pre-market Notification Details

Device IDK920257
510k NumberK920257
Device Name:NIACIN CONTROL DISKS
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactFeiring, Jr.
CorrespondentFeiring, Jr.
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-21
Decision Date1992-04-22

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