CALCOFLUOR WHITE STAIN KIT

Stains, Microbiologic

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Calcofluor White Stain Kit.

Pre-market Notification Details

Device IDK880718
510k NumberK880718
Device Name:CALCOFLUOR WHITE STAIN KIT
ClassificationStains, Microbiologic
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactBrenda Henry
CorrespondentBrenda Henry
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 Received1988-02-23
Decision Date1988-03-25

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