EZTEST

Indicator, Biological Sterilization Process

SGM BIOTECH, INC.

The following data is part of a premarket notification filed by Sgm Biotech, Inc. with the FDA for Eztest.

Pre-market Notification Details

• Device ID: K963841
• 510k Number: K963841
• Device Name: EZTEST
• Classification: Indicator, Biological Sterilization Process
• Applicant: SGM BIOTECH, INC. 10 EVERGREEN DR. SUITE E Bozeman, MT 59715
• Contact: John R Gillis
• Correspondent: John R Gillis; SGM BIOTECH, INC. 10 EVERGREEN DR. SUITE E Bozeman, MT 59715
• Product Code: FRC
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-25
• Decision Date: 1997-02-25
• Summary: summary