FORMICAL

Solution, Decalcifier, Acid Containing

LERNER LABORATORIES, INC.

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

Pre-market Notification Details

• Device ID: K821443
• 510k Number: K821443
• Device Name: FORMICAL
• Classification: Solution, Decalcifier, Acid Containing
• Applicant: LERNER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KDX
• CFR Regulation Number: 864.4010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-05-14
• Decision Date: 1982-06-02