The following data is part of a premarket notification filed by Nms Pharmaceuticals, Inc. with the FDA for Histamine Ria Test For Histamine Biological Fluids.
| Device ID | K854236 |
| 510k Number | K854236 |
| Device Name: | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS |
| Classification | Wright's Stain |
| Applicant | NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry C Rucker |
| Correspondent | Perry C Rucker NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | IAF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1986-10-10 |