CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY

Antisera, Conjugated Fluorescent, Cytomegalovirus

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Cytomegalovirus Fluorescent Monoclonal Antibody.

Pre-market Notification Details

• Device ID: K894002
• 510k Number: K894002
• Device Name: CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
• Classification: Antisera, Conjugated Fluorescent, Cytomegalovirus
• Applicant: BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009
• Contact: Lorraine Weaver
• Correspondent: Lorraine Weaver; BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009
• Product Code: LIN
• CFR Regulation Number: 866.3175 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-06-05
• Decision Date: 1989-08-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516745888	K894002	000
05391516745871	K894002	000
05391516745161	K894002	000