The following data is part of a premarket notification filed by Nms Pharmaceuticals, Inc. with the FDA for Quantitative Determination Of Hcg In Serum-elisa.
| Device ID | K853925 |
| 510k Number | K853925 |
| Device Name: | QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-12-02 |