The following data is part of a premarket notification filed by Sun Biomedical Laboratories, Inc. with the FDA for Visualine Ii Hcg.
| Device ID | K943239 |
| 510k Number | K943239 |
| Device Name: | VISUALINE II HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. Cherry Hill, NJ 08003 |
| Contact | Ming Sun |
| Correspondent | Ming Sun SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. Cherry Hill, NJ 08003 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-12-07 |