The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for First Response 10 Minute Ovulation Predictor Test.
| Device ID | K883530 |
| 510k Number | K883530 |
| Device Name: | FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Barbara M Davis,phd |
| Correspondent | Barbara M Davis,phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-18 |
| Decision Date | 1988-12-19 |