The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Ovu Stick Urine Hlh Kit.
| Device ID | K840412 |
| 510k Number | K840412 |
| Device Name: | OVU STICK URINE HLH KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | MONOCLONAL ANTIBODIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-04-13 |