The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Urine Magnesium Method For Technicon Chem Systems.
| Device ID | K926144 |
| 510k Number | K926144 |
| Device Name: | URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS |
| Classification | Photometric Method, Magnesium |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Muraca, Jr. |
| Correspondent | Muraca, Jr. HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-07 |
| Decision Date | 1993-01-27 |