FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
MAGNESIUM ASSAY
K Number: K111915
·
Decision Dec 2, 2011
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
6
Review Days
149
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAGNESIUM ASSAY
- K Number
- K111915
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Date Received
- July 6, 2011
- Decision Date
- December 2, 2011
- Product Code
- JGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGJ), ordered by most recent decision date.
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Randox RX Daytona Plus Magnesium (MG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE MAGNESIUM REGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EASYRA MG REAGENT, MODEL 10220
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Sekisui Diagnostics P.E.I., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202644 | Acetaminophen | Feb 18, 2022 | Substantially Equivalent |
| K182702 | SEKURE Creatine Kinase Assay | Apr 17, 2019 | Substantially Equivalent |
| K180835 | SEKURE Acetaminophen L3K Assay | Feb 8, 2019 | Substantially Equivalent |
| K173206 | SEKURE HbA1c Assay | Jul 12, 2018 | Substantially Equivalent |
| K163078 | DC-UIBC-CAL | Dec 8, 2016 | Substantially Equivalent |