The following data is part of a premarket notification filed by Sekisui Diagnostics P.e.i. Inc. with the FDA for Magnesium Assay.
| Device ID | K111915 |
| 510k Number | K111915 |
| Device Name: | MAGNESIUM ASSAY |
| Classification | Photometric Method, Magnesium |
| Applicant | SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE CHARLOTTETOWN Prince Edward Island, CA C1e2b9 |
| Contact | Penny J White |
| Correspondent | Penny J White SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE CHARLOTTETOWN Prince Edward Island, CA C1e2b9 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-06 |
| Decision Date | 2011-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401031 | K111915 | 000 |
| 00628063400799 | K111915 | 000 |