The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem (tm)serum Iron And Tibc Reagents.
| Device ID | K864819 |
| 510k Number | K864819 |
| Device Name: | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | E.peacock, Jr |
| Correspondent | E.peacock, Jr REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-12 |