TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

Calibrator, Secondary

REFERENCE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Total Iron-binding Capacity Calibrator Set. Direct Tibc Calibrator Set.

Pre-market Notification Details

Device IDK052148
510k NumberK052148
Device Name:TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
ClassificationCalibrator, Secondary
Applicant REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford,  MA  01730
ContactJoseph Lawlor
CorrespondentJoseph Lawlor
REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford,  MA  01730
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-08
Decision Date2005-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727011657 K052148 000
00817439021274 K052148 000
00845275003772 K052148 000

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