CBC-SF

Mixture, Hematology Quality Control

R & D SYSTEMS, INC.

The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-sf.

Pre-market Notification Details

Device IDK010409
510k NumberK010409
Device Name:CBC-SF
ClassificationMixture, Hematology Quality Control
Applicant R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
ContactKenneth T Edds
CorrespondentKenneth T Edds
R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-12
Decision Date2001-03-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815762020858 K010409 000
00815762020841 K010409 000

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