The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Trace Magnesium - Arsenazo Reagent.
| Device ID | K920603 |
| 510k Number | K920603 |
| Device Name: | TRACE MAGNESIUM - ARSENAZO REAGENT |
| Classification | Photometric Method, Magnesium |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-01 |
| Decision Date | 1992-03-11 |