The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Ovustick Self-test.
| Device ID | K843284 |
| 510k Number | K843284 |
| Device Name: | OVUSTICK SELF-TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| 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 | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-12-11 |