The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Urea Nitrogen (color) Reagent.
| Device ID | K896845 |
| 510k Number | K896845 |
| Device Name: | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT |
| Classification | Berthelot Indophenol, Urea Nitrogen |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | J Shrawder,phd |
| Correspondent | J Shrawder,phd REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | CDL |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-06 |
| Decision Date | 1990-02-16 |