The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs Tobramycin.
| Device ID | K974029 |
| 510k Number | K974029 |
| Device Name: | ACS TOBRAMYCIN |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-23 |
| Decision Date | 1998-02-12 |
| Summary: | summary |