The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for One Step Eddp (methadone Metabolite) Test Strip.
| Device ID | K092048 |
| 510k Number | K092048 |
| Device Name: | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Lisa Chicorka |
| Correspondent | Lisa Chicorka BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2010-04-19 |
| Summary: | summary |