The following data is part of a premarket notification filed by Sgm Biotech, Inc. with the FDA for Smart-read Eztest-steam Scbi And Test Pack.
| Device ID | K093794 |
| 510k Number | K093794 |
| Device Name: | SMART-READ EZTEST-STEAM SCBI AND TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SGM BIOTECH, INC. 10 EVERGREEN DR. SUITE E Bozeman, MT 59715 |
| Contact | John R Gillis, Ph.d. |
| Correspondent | John R Gillis, Ph.d. SGM BIOTECH, INC. 10 EVERGREEN DR. SUITE E Bozeman, MT 59715 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-05-14 |
| Summary: | summary |