The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Ramp Urine Hcg Assay.
| Device ID | K854611 |
| 510k Number | K854611 |
| Device Name: | RAMP URINE HCG ASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MONOCLONAL ANTIBODIES, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Michael C Maloney |
| Correspondent | Michael C Maloney MONOCLONAL ANTIBODIES, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1985-12-30 |