The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Magnesium Reagent.
| Device ID | K944407 |
| 510k Number | K944407 |
| Device Name: | OLYMPUS MAGNESIUM REAGENT |
| Classification | Photometric Method, Magnesium |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1994-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590010850 | K944407 | 000 |