R&D SICKLE QC CONTROL

Control, Hemoglobin

R & D SYSTEMS, INC.

The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Sickle Qc Control.

Pre-market Notification Details

Device IDK070334
510k NumberK070334
Device Name:R&D SICKLE QC CONTROL
ClassificationControl, Hemoglobin
Applicant R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
ContactRalph E Hogancamp
CorrespondentRalph E Hogancamp
R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
Product CodeGGM  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-05
Decision Date2007-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815762021442 K070334 000
00815762021435 K070334 000

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