BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2

Antisera, Fluorescent, Herpesvirus Hominis 1,2

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Bartels Herpes Simplex Vir Flu Mono Antib Hsv-1&2.

Pre-market Notification Details

• Device ID: K902661
• 510k Number: K902661
• Device Name: BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
• Classification: Antisera, Fluorescent, Herpesvirus Hominis 1,2
• Applicant: BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009
• Contact: Lorraine W Huffman
• Correspondent: Lorraine W Huffman; BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009
• Product Code: GQL
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-18
• Decision Date: 1990-07-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516745864	K902661	000
05391516745826	K902661	000