BLOOD FLUID FILTERS

Tubes, Vials, Systems, Serum Separators, Blood Collection

DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Blood Fluid Filters.

Pre-market Notification Details

Device IDK792723
510k NumberK792723
Device Name:BLOOD FLUID FILTERS
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant DADE, BAXTER TRAVENOL DIAGNOSTICS, 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 Received1979-12-31
Decision Date1980-01-21

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