UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

Ferrozine (colorimetric) Iron Binding Capacity

DIAGNOSTIC CHEMICALS LTD.

The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Unsaturated Iron Binding Capacity (uibc) Assay.

Pre-market Notification Details

Device IDK963116
510k NumberK963116
Device Name:UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
ClassificationFerrozine (colorimetric) Iron Binding Capacity
Applicant DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i.,  CA C1e 2a6
ContactKaren Callbeck, R.t.b.sc.
CorrespondentKaren Callbeck, R.t.b.sc.
DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i.,  CA C1e 2a6
Product CodeJMO  
CFR Regulation Number862.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-12
Decision Date1996-08-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628063400959 K963116 000
00628063400942 K963116 000
00628063400935 K963116 000
00628063400928 K963116 000

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