The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tdm Control Set, Model Cat# 04521536.
| Device ID | K070200 |
| 510k Number | K070200 |
| Device Name: | TDM CONTROL SET, MODEL CAT# 04521536 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Dimitris Demirtzoglou |
| Correspondent | Dimitris Demirtzoglou ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-03-19 |
| Summary: | summary |