The following data is part of a premarket notification filed by Giles Scientific, Inc. with the FDA for Biogram.
| Device ID | K843725 |
| 510k Number | K843725 |
| Device Name: | BIOGRAM |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | GILES SCIENTIFIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1985-05-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOGRAM 97159394 not registered Live/Pending |
AURA Devices, Inc. 2021-12-07 |
![]() BIOGRAM 78576439 not registered Dead/Abandoned |
Summit Life Systems, LLC 2005-02-28 |
![]() BIOGRAM 73583305 not registered Dead/Abandoned |
GIBBS, DAVID L. 1986-02-18 |
![]() BIOGRAM 73168499 1106988 Dead/Expired |
WILLIAM T. THOMPSON COMPANY 1978-05-01 |
![]() BIOGRAM 72302085 0887183 Dead/Expired |
INDUSTRIAL BIO-TEST LABORATORIES, INC. 1968-07-05 |