The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Online Theophylline.
| Device ID | K020740 |
| 510k Number | K020740 |
| Device Name: | ROCHE ONLINE THEOPHYLLINE |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Mike Flis |
| Correspondent | Mike Flis ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336147931 | K020740 | 000 |