CD-CAL PLUS CALIBRATOR

Calibrator For Cell Indices

R & D SYSTEMS, INC.

The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cd-cal Plus Calibrator.

Pre-market Notification Details

Device IDK003991
510k NumberK003991
Device Name:CD-CAL PLUS CALIBRATOR
ClassificationCalibrator For Cell Indices
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 CodeKRX  
Subsequent Product CodeKRY
Subsequent Product CodeKRZ
Subsequent Product CodeKSA
CFR Regulation Number864.8150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-26
Decision Date2001-01-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817274020258 K003991 000
20815762020937 K003991 000

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