DUPONT ISOLATOR 1.5 MICROBIAL TUBE

Device, Specimen Collection

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Isolator 1.5 Microbial Tube.

Pre-market Notification Details

Device IDK832246
510k NumberK832246
Device Name:DUPONT ISOLATOR 1.5 MICROBIAL TUBE
ClassificationDevice, Specimen Collection
Applicant E.I. DUPONT DE NEMOURS & CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLIO  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-11
Decision Date1983-09-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811877010958 K832246 000

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