PLATELET-TROL II

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 Platelet-trol Ii.

Pre-market Notification Details

Device IDK854353
510k NumberK854353
Device Name:PLATELET-TROL II
ClassificationMixture, Hematology Quality Control
Applicant R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
ContactDale Christensen
CorrespondentDale Christensen
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 Received1985-10-28
Decision Date1985-11-26

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