SPINSEP-FE59

Radiometric, Fe59, Iron Binding Capacity

NUCLEAR DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Spinsep-fe59.

Pre-market Notification Details

Device IDK790133
510k NumberK790133
Device Name:SPINSEP-FE59
ClassificationRadiometric, Fe59, Iron Binding Capacity
Applicant NUCLEAR DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJQG  
CFR Regulation Number862.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-23
Decision Date1979-03-02

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