The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem/k.e.
| Device ID | K854540 |
| 510k Number | K854540 |
| Device Name: | RAICHEM/K.E |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Alfred E Peacock |
| Correspondent | Alfred E Peacock REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1985-11-26 |