AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL

Bromcresol Green Dye-binding, Albumin

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Auto-albumin Reag For Gilford 3400e Anal.

Pre-market Notification Details

Device IDK761026
510k NumberK761026
Device Name:AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL
ClassificationBromcresol Green Dye-binding, Albumin
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-11-12
Decision Date1976-11-30

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