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 |