The following data is part of a premarket notification filed by Nms Pharmaceuticals, Inc. with the FDA for Color Ovulation Test.
| Device ID | K851445 |
| 510k Number | K851445 |
| Device Name: | COLOR OVULATION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry G Rucker |
| Correspondent | Perry G Rucker NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-07-29 |