SERUM IRON/VIBC REAGENT SET

Photometric Method, Iron (non-heme)

LIVONIA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Livonia Diagnostics, Inc. with the FDA for Serum Iron/vibc Reagent Set.

Pre-market Notification Details

Device IDK852161
510k NumberK852161
Device Name:SERUM IRON/VIBC REAGENT SET
ClassificationPhotometric Method, Iron (non-heme)
Applicant LIVONIA DIAGNOSTICS, INC. 33041 W. EIGHT MILE RD. Livonia,  MI  48152
ContactWalter H Lambert
CorrespondentWalter H Lambert
LIVONIA DIAGNOSTICS, INC. 33041 W. EIGHT MILE RD. Livonia,  MI  48152
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-20
Decision Date1985-06-10

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