The following data is part of a premarket notification filed by Giles Scientific, Inc. with the FDA for Biomic Microbiology Data Management System.
| Device ID | K944319 |
| 510k Number | K944319 |
| Device Name: | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM |
| Classification | Reader, Zone, Automated |
| 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 | KZK |
| CFR Regulation Number | 866.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-12-15 |