The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Oral Fluid Phencyclidine.
| Device ID | K093989 |
| 510k Number | K093989 |
| Device Name: | ORAL FLUID PHENCYCLIDINE |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Michelle Lee Neff |
| Correspondent | Michelle Lee Neff Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | LCM |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2011-01-25 |
| Summary: | summary |