The following data is part of a premarket notification filed by Sun Biomedical Laboratories, Inc. with the FDA for Visualine Ii Cocaine.
| Device ID | K950369 |
| 510k Number | K950369 |
| Device Name: | VISUALINE II COCAINE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. Cherry Hill, NJ 08003 -1612 |
| Contact | Ming Sun |
| Correspondent | Ming Sun SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. Cherry Hill, NJ 08003 -1612 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-03-21 |