The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Phenobarbital.
| Device ID | K953021 |
| 510k Number | K953021 |
| Device Name: | ACS PHENOBARBITAL |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Steve R Rakitin |
| Correspondent | Steve R Rakitin CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-29 |
| Decision Date | 1995-12-11 |