CBC-LINE HEMATOLOGY LINEARITY CONTROL

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-line Hematology Linearity Control.

Pre-market Notification Details

• Device ID: K942822
• 510k Number: K942822
• Device Name: CBC-LINE HEMATOLOGY LINEARITY CONTROL
• Classification: Mixture, Hematology Quality Control
• Applicant: R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413
• Contact: Sue Gallo
• Correspondent: Sue Gallo; R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-15
• Decision Date: 1994-10-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815762021954	K942822	000
00815762020742	K942822	000
00815762020735	K942822	000
00815762020728	K942822	000
00815762020711	K942822	000
00815762020698	K942822	000
00815762020681	K942822	000
00815762020667	K942822	000
00815762020650	K942822	000
00815762020643	K942822	000
00815762020636	K942822	000
00815762020629	K942822	000
00815762020612	K942822	000
00815762020599	K942822	000
00815762020582	K942822	000
00815762020575	K942822	000
00815762020568	K942822	000
00815762020759	K942822	000
00815762021183	K942822	000
00815762021190	K942822	000
00815762021947	K942822	000
00815762021930	K942822	000
00815762021923	K942822	000
00815762021862	K942822	000
00815762021855	K942822	000
00815762021848	K942822	000
00815762021831	K942822	000
00815762021824	K942822	000
00815762021817	K942822	000
00815762021800	K942822	000
00815762021794	K942822	000
00815762021787	K942822	000
00815762021770	K942822	000
00815762021763	K942822	000
00815762021626	K942822	000
00815762021619	K942822	000
00815762020551	K942822	000