ELDONCARD

System, Test, Automated Blood Grouping And Antibody

NORDISK INFUSER SYSTEM

The following data is part of a premarket notification filed by Nordisk Infuser System with the FDA for Eldoncard.

Pre-market Notification Details

• Device ID: K790282
• 510k Number: K790282
• Device Name: ELDONCARD
• Classification: System, Test, Automated Blood Grouping And Antibody
• Applicant: NORDISK INFUSER SYSTEM 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: KSZ
• CFR Regulation Number: 864.9175 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-02-13
• Decision Date: 1979-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713494000511	K790282	000
05713494000054	K790282	000
05713494000047	K790282	000
05713494000030	K790282	000
05713494000023	K790282	000
05713494000016	K790282	000
05713494000528	K790282	000
05713494000535	K790282	000
05713494001754	K790282	000
05713494000306	K790282	000
05713494000313	K790282	000
05713494001990	K790282	000
05713494002270	K790282	000
05713494001778	K790282	000
05713494001761	K790282	000
05713494002409	K790282	000
05713494002638	K790282	000
05713494000078	K790282	000
05713494000085	K790282	000
05713494000504	K790282	000
05713494000498	K790282	000
05713494000481	K790282	000
05713494000467	K790282	000
05713494000450	K790282	000
05713494000412	K790282	000
05713494000405	K790282	000
05713494000399	K790282	000
05713494000382	K790282	000
05713494000375	K790282	000
05713494000368	K790282	000
05713494000351	K790282	000
05713494000344	K790282	000
05713494000115	K790282	000
05713494000108	K790282	000
05713494000092	K790282	000
05713494002690	K790282	000