The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Online Tdm Quinidine.
| Device ID | K032332 |
| 510k Number | K032332 |
| Device Name: | ROCHE ONLINE TDM QUINIDINE |
| Classification | Enzyme Immunoassay, Quinidine |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Mike Flis |
| Correspondent | Mike Flis ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-29 |
| Decision Date | 2004-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336147917 | K032332 | 000 |