TITAN GEL

Gamma Globulin, Antigen, Antiserum, Control

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel.

Pre-market Notification Details

• Device ID: K905149
• 510k Number: K905149
• Device Name: TITAN GEL
• Classification: Gamma Globulin, Antigen, Antiserum, Control
• Applicant: HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Contact: Pat Franks
• Correspondent: Pat Franks; HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Product Code: DAH
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-15
• Decision Date: 1991-01-03