ZITHROMAX

Chromatographic, Phospholipids

DIFCO LABORATORIES, INC.

The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Zithromax.

Pre-market Notification Details

• Device ID: K922792
• 510k Number: K922792
• Device Name: ZITHROMAX
• Classification: Chromatographic, Phospholipids
• Applicant: DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058
• Contact: David W Gates
• Correspondent: David W Gates; DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058
• Product Code: JNT
• CFR Regulation Number: 862.1575 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-09
• Decision Date: 1992-07-30