The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Ovuquick Self-test (ovuquick; Ramp Lh Assay).
| Device ID | K871726 |
| 510k Number | K871726 |
| Device Name: | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | MONOCLONAL ANTIBODIES, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Griffin Fitzgerald |
| Correspondent | Griffin Fitzgerald MONOCLONAL ANTIBODIES, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-07-27 |