CBC PLT-4

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 Plt-4.

Pre-market Notification Details

Device IDK802265
510k NumberK802265
Device Name:CBC PLT-4
ClassificationMixture, Hematology Quality Control
Applicant R & D SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-16
Decision Date1980-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00815762021053 K802265 000
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00815762021107 K802265 000
20815762020340 K802265 000

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