SELECTIVE GC CULTURE MEDIUM

Culture Media, For Isolation Of Pathogenic Neisseria

BIOLOG, INC.

The following data is part of a premarket notification filed by Biolog, Inc. with the FDA for Selective Gc Culture Medium.

Pre-market Notification Details

• Device ID: K811282
• 510k Number: K811282
• Device Name: SELECTIVE GC CULTURE MEDIUM
• Classification: Culture Media, For Isolation Of Pathogenic Neisseria
• Applicant: BIOLOG, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JTY
• CFR Regulation Number: 866.2410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-08
• Decision Date: 1981-06-12