RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE

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 Retic Control-h Hematology Control/multiple.

Pre-market Notification Details

Device IDK943336
510k NumberK943336
Device Name:RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
ClassificationMixture, Hematology Quality Control
Applicant R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis,  MN  55413
ContactSue Gallo
CorrespondentSue Gallo
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 Received1994-07-12
Decision Date1994-12-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903410002 K943336 000
00382903409990 K943336 000

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