STATUSFLOW

Counter, Differential Cell

R & D SYSTEMS, INC.

The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Statusflow.

Pre-market Notification Details

Device IDK982231
510k NumberK982231
Device Name:STATUSFLOW
ClassificationCounter, Differential Cell
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 CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-25
Decision Date1998-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903497058 K982231 000
00382903497041 K982231 000
00382903497034 K982231 000
00382903409167 K982231 000
00382903409150 K982231 000
00382903409143 K982231 000

Trademark Results [STATUSFLOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STATUSFLOW
STATUSFLOW
75134311 2107999 Live/Registered
Research & Diagnostic Systems, Inc.
1996-07-15

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