The following data is part of a premarket notification filed by Sun Biomedical Laboratories, Inc. with the FDA for Visualine Barbiturates Dipstrip Test.
| Device ID | K020136 |
| 510k Number | K020136 |
| Device Name: | VISUALINE BARBITURATES DIPSTRIP TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-15 |
| Decision Date | 2002-03-20 |
| Summary: | summary |