The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Gentamicin.
| Device ID | K953020 |
| 510k Number | K953020 |
| Device Name: | ACS GENTAMICIN |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Steven R Rakitin |
| Correspondent | Steven R Rakitin CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-29 |
| Decision Date | 1995-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414527307 | K953020 | 000 |
| 00630414527291 | K953020 | 000 |
| 00630414527284 | K953020 | 000 |
| 00630414527277 | K953020 | 000 |