The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Calcium:arsenazo Iii.
| Device ID | K902476 |
| 510k Number | K902476 |
| Device Name: | CALCIUM:ARSENAZO III |
| Classification | Azo Dye, Calcium |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Patel, Ph.d. |
| Correspondent | Patel, Ph.d. AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-07-17 |