The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for First Response Ovulation Predictor Test.
| Device ID | K953581 |
| 510k Number | K953581 |
| Device Name: | FIRST RESPONSE OVULATION PREDICTOR TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-01 |
| Decision Date | 1995-10-03 |