ISOSTAT MICROBIAL TUBE PROCESSING

Tubes, Vials, Systems, Serum Separators, Blood 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 Isostat Microbial Tube Processing.

Pre-market Notification Details

Device IDK840496
510k NumberK840496
Device Name:ISOSTAT MICROBIAL TUBE PROCESSING
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant E.I. DUPONT DE NEMOURS & CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-06
Decision Date1984-04-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811877010064 K840496 000
00811877010098 K840496 000
00811877010050 K840496 000

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