The following data is part of a premarket notification filed by Giles Scientific, Inc. with the FDA for Biogram.
| Device ID | K854521 |
| 510k Number | K854521 |
| Device Name: | BIOGRAM |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | GILES SCIENTIFIC, INC. 250 MERCER ST. SUITE A301 New York, NY 10012 |
| Contact | David L Gibbs |
| Correspondent | David L Gibbs GILES SCIENTIFIC, INC. 250 MERCER ST. SUITE A301 New York, NY 10012 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-23 |
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 |