The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for O.p.t.(tm) Ovulation Prediction Test.
| Device ID | K870584 |
| 510k Number | K870584 |
| Device Name: | O.P.T.(TM) OVULATION PREDICTION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Clark, Phd |
| Correspondent | Clark, Phd WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-11 |
| Decision Date | 1987-11-25 |