QBC CENTRIFUGAL HEMATOLOGY CONTROL

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 Qbc Centrifugal Hematology Control.

Pre-market Notification Details

Device IDK984099
510k NumberK984099
Device Name:QBC CENTRIFUGAL HEMATOLOGY CONTROL
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-17
Decision Date1998-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858092006543 K984099 000
00858092006277 K984099 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.