The following data is part of a premarket notification filed by Genzyme Diagnostics with the FDA for Osom Hcg Combo Test.
| Device ID | K043385 |
| 510k Number | K043385 |
| Device Name: | OSOM HCG COMBO TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | GENZYME DIAGNOSTICS 6659 TOP GUN ST. San Diego, CA 92121 |
| Contact | E.v. Goorchenko |
| Correspondent | E.v. Goorchenko GENZYME DIAGNOSTICS 6659 TOP GUN ST. San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-09 |
| Decision Date | 2005-04-12 |
| Summary: | summary |