The following data is part of a premarket notification filed by Sun Biomedical Laboratories, Inc. with the FDA for Visualine V Drugs Of Abuse Dipstrip Panel For Qualitative Determination Of Cocaine, Cannabinoids, Morphine, Methampe.
| Device ID | K993485 |
| 510k Number | K993485 |
| Device Name: | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-14 |
| Decision Date | 1999-12-27 |
| Summary: | summary |