The following data is part of a premarket notification filed by Sgm Biotech, Inc. with the FDA for Eztest.
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EZTEST  85081562  4014851 Live/Registered | MESA LABORATORIES, INC. 2010-07-09 | 
|  EZTEST  79401652  not registered Live/Pending | ABB Asea Brown Boveri Ltd 2024-05-14 | 
|  EZTEST  74063633  1647985 Live/Registered | SGM Biotech, Inc. 1990-05-29 |