The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Dat Phencyclidine Plus.
| Device ID | K043305 |
| 510k Number | K043305 |
| Device Name: | ONLINE DAT PHENCYCLIDINE PLUS |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-30 |
| Decision Date | 2005-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121450 | K043305 | 000 |