The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche-tdm Onlein(tm) Controls.
| Device ID | K946119 |
| 510k Number | K946119 |
| Device Name: | ROCHE-TDM ONLEIN(TM) CONTROLS |
| Classification | Drug Specific Control Materials |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-15 |
| Decision Date | 1995-02-07 |