IGE-QUANT DIAGNOSTIC TEST KIT

Ige, Antigen, Antiserum, Control

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Ige-quant Diagnostic Test Kit.

Pre-market Notification Details

Device IDK831208
510k NumberK831208
Device Name:IGE-QUANT DIAGNOSTIC TEST KIT
ClassificationIge, Antigen, Antiserum, Control
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-14
Decision Date1983-05-09

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