The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Spia(tm) Crp Reagent.
| Device ID | K902593 |
| 510k Number | K902593 |
| Device Name: | RAICHEM(TM) SPIA(TM) CRP REAGENT |
| Classification | System, Test, C-reactive Protein |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Neumann, Phd |
| Correspondent | Neumann, Phd REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-06-28 |