MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

Multi-analyte Controls, All Kinds (assayed)

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Modification To N/t Rheumatology Controls Sl 1 & 2.

Pre-market Notification Details

• Device ID: K021381
• 510k Number: K021381
• Device Name: MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702
• Contact: Donna A Wolf
• Correspondent: Donna A Wolf; DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-01
• Decision Date: 2002-06-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768007279	K021381	000
00842768007262	K021381	000
00630414287423	K021381	000
00630414287416	K021381	000