The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Tri-level Ligand Control.
| Device ID | K873450 |
| 510k Number | K873450 |
| Device Name: | TRI-LEVEL LIGAND CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Schaefer, Phd |
| Correspondent | Schaefer, Phd CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-27 |
| Decision Date | 1987-09-21 |