The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Bhcg-roche Eia.
| Device ID | K850727 |
| 510k Number | K850727 |
| Device Name: | BHCG-ROCHE EIA |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | HOFFMANN-LA ROCHE, INC. 340 KINGSLAND ST. Nutley, NJ 07110 -1199 |
| Contact | Griffin Fitzgerald |
| Correspondent | Griffin Fitzgerald HOFFMANN-LA ROCHE, INC. 340 KINGSLAND ST. Nutley, NJ 07110 -1199 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-22 |
| Decision Date | 1985-06-25 |