DISCS

Discs, Strips And Reagents, Microorganism Differentiation

ANAEROBE SYSTEMS

The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Discs.

Pre-market Notification Details

• Device ID: K840028
• 510k Number: K840028
• Device Name: DISCS
• Classification: Discs, Strips And Reagents, Microorganism Differentiation
• Applicant: ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JTO
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-01-05
• Decision Date: 1984-03-02