DIAGNOSTIC KIT, FERRITAB-FE-59

Radio-labeled Iron Method, Iron (non-heme)

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Diagnostic Kit, Ferritab-fe-59.

Pre-market Notification Details

Device IDK782159
510k NumberK782159
Device Name:DIAGNOSTIC KIT, FERRITAB-FE-59
ClassificationRadio-labeled Iron Method, Iron (non-heme)
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJA  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-22
Decision Date1979-02-01

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