The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Preciset Tdm I And Preciset Tdm Ii Calibrators.
| Device ID | K031856 |
| 510k Number | K031856 |
| Device Name: | PRECISET TDM I AND PRECISET TDM II CALIBRATORS |
| Classification | Calibrators, Drug Mixture |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-08-06 |
| Summary: | summary |