N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

Method, Nephelometric, Immunoglobulins (g, A, M)

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Antisera To Human Immunoglobulins (igg, Iga And Igm).

Pre-market Notification Details

• Device ID: K042735
• 510k Number: K042735
• Device Name: N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
• Classification: Method, Nephelometric, Immunoglobulins (g, A, M)
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714
• Contact: Kathleen A Dray-lyons
• Correspondent: Kathleen A Dray-lyons; DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714
• Product Code: CFN
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-01
• Decision Date: 2005-02-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768009846	K042735	000
00842768009822	K042735	000
00842768009761	K042735	000
00842768009747	K042735	000