NEPHROLYTE

Methylene Blue, Tissue Stain

FLAITRON LABORATORIES, INC.

The following data is part of a premarket notification filed by Flaitron Laboratories, Inc. with the FDA for Nephrolyte.

Pre-market Notification Details

Device IDK831502
510k NumberK831502
Device Name:NEPHROLYTE
ClassificationMethylene Blue, Tissue Stain
Applicant FLAITRON LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKFC  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-11
Decision Date1983-07-18

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