The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Calcium (arsenazo Iii) Reagent.
| Device ID | K894204 |
| 510k Number | K894204 |
| Device Name: | CALCIUM (ARSENAZO III) REAGENT |
| Classification | Azo Dye, Calcium |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-10-04 |