MAGNESIUM
FDA 510(k) clearance K874847 · decided 1987-12-18
Clearance details
- K-number
- K874847
- Device name
- MAGNESIUM
- Applicant
- Tech-Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-24
- Decision date
- 1987-12-18
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JGJ
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oak Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Magnesium (K181748) | Abbott Laboratories | 2018-09-12 |
| Magnesium (K173294) | Abbott Laboratories | 2018-05-18 |
| Randox RX Daytona Plus Magnesium (MG) (K162200) | Randox Laboratories, Ltd. | 2017-04-28 |
| Atellica CH Magnesium (Mg) (K162399) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 |
| ACE MAGNESIUM REGENT (K122302) | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| MAGNESIUM ASSAY (K111915) | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| EASYRA MG REAGENT, MODEL 10220 (K092737) | Medica Corp. | 2009-11-17 |
| PICCOLO MAGNESIUM TEST SYSTEM (K091910) | Abaxis, Inc. | 2009-10-01 |
| MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208) | Diagnostic Chemicals , Ltd. | 2007-01-19 |
| VITALAB MAGNESIUM REAGENT (K040508) | Clinical Data, Inc. | 2004-03-08 |
| PICCOLO MAGNESIUM TEST SYSTEM (K040115) | Abaxis, Inc. | 2004-01-30 |
| ATAC PAK MAGNESIUM REAGENT (K030010) | Elan Diagnostics | 2003-03-10 |
Recalls involving this device
No recalls on record reference this clearance.