BIOFIX

Fixative, Alcohol Containing

ACCRA LABORATORIES, INC.

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

Pre-market Notification Details

• Device ID: K843428
• 510k Number: K843428
• Device Name: BIOFIX
• Classification: Fixative, Alcohol Containing
• Applicant: ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LDZ
• CFR Regulation Number: 864.4010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-09-04
• Decision Date: 1984-09-27