BACTI-SWAB(TM) NPG

Device, Specimen Collection

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Bacti-swab(tm) Npg.

Pre-market Notification Details

Device IDK912832
510k NumberK912832
Device Name:BACTI-SWAB(TM) NPG
ClassificationDevice, Specimen Collection
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactAnn Silvius
CorrespondentAnn Silvius
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeLIO  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-26
Decision Date1991-08-22

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