The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Calcium Arsenazo Iii Reagent.
| Device ID | K903896 |
| 510k Number | K903896 |
| Device Name: | CALCIUM ARSENAZO III REAGENT |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168, AU 3168 |
| Contact | Peter Murphy |
| Correspondent | Peter Murphy TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168, AU 3168 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1990-09-13 |