The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Calcium Reagent (single Stable Liquid).
| Device ID | K880576 |
| 510k Number | K880576 |
| Device Name: | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) |
| Classification | Azo Dye, Calcium |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Alfred E Peacock,jr |
| Correspondent | Alfred E Peacock,jr REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-06-10 |