The following data is part of a premarket notification filed by Sun Biomedical Laboratories, Inc. with the FDA for Visualine Ii (also Known As Sunline) Methadone.
| Device ID | K981314 |
| 510k Number | K981314 |
| Device Name: | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | SUN BIOMEDICAL LABORATORIES, INC. 604 VPR CENTER 1001 LOWER LANDING RD. Blackwood, NJ 08012 |
| Contact | Ming Sun |
| Correspondent | Ming Sun SUN BIOMEDICAL LABORATORIES, INC. 604 VPR CENTER 1001 LOWER LANDING RD. Blackwood, NJ 08012 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-09-04 |