BACTIDROP INDIA INK

Stains, Microbiologic

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop India Ink.

Pre-market Notification Details

Device IDK920976
510k NumberK920976
Device Name:BACTIDROP INDIA INK
ClassificationStains, Microbiologic
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactAnn Silvius
CorrespondentAnn Silvius
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTS  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-02
Decision Date1992-06-09

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