RAPITEX(R) RF NEW

System, Test, Rheumatoid Factor

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Rapitex(r) Rf New.

Pre-market Notification Details

• Device ID: K903852
• 510k Number: K903852
• Device Name: RAPITEX(R) RF NEW
• Classification: System, Test, Rheumatoid Factor
• Applicant: BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876
• Contact: John E Hughes
• Correspondent: John E Hughes; BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876
• Product Code: DHR
• CFR Regulation Number: 866.5775 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-08-21
• Decision Date: 1990-08-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768012754	K903852	000
00842768011061	K903852	000
00842768011054	K903852	000