The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas (r) Core T4 Eia.
| Device ID | K932605 |
| 510k Number | K932605 |
| Device Name: | COBAS (R) CORE T4 EIA |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1994-01-24 |