The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Lightcycler Instrument Version 1.2.
| Device ID | K033734 |
| 510k Number | K033734 |
| Device Name: | LIGHTCYCLER INSTRUMENT VERSION 1.2 |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Robert A Gregg |
| Correspondent | Robert A Gregg ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2003-12-17 |
| Summary: | summary |