SDI PREPAX DILUKIT HW

Diluent, Blood Cell

SCIENTIFIC DISTRIBUTORS, INC.

The following data is part of a premarket notification filed by Scientific Distributors, Inc. with the FDA for Sdi Prepax Dilukit Hw.

Pre-market Notification Details

Device IDK840041
510k NumberK840041
Device Name:SDI PREPAX DILUKIT HW
ClassificationDiluent, Blood Cell
Applicant SCIENTIFIC DISTRIBUTORS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGIF  
CFR Regulation Number864.8200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-06
Decision Date1984-03-05

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