The following data is part of a premarket notification filed by Alfa Wassermann Diagnostics Technologies, Llc with the FDA for Ace Magnesium Regent.
| Device ID | K122302 |
| 510k Number | K122302 |
| Device Name: | ACE MAGNESIUM REGENT |
| Classification | Photometric Method, Magnesium |
| Applicant | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-08-27 |
| Summary: | summary |