The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020.
| Device ID | K023252 |
| 510k Number | K023252 |
| Device Name: | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | ICN BIOMEDICALS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Contact | Charles C.f. Yu |
| Correspondent | Charles C.f. Yu ICN BIOMEDICALS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-11-22 |
| Summary: | summary |