Magnesium
FDA 510(k) clearance K181748 · decided 2018-09-12
Clearance details
- K-number
- K181748
- Device name
- Magnesium
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2018-07-02
- Decision date
- 2018-09-12
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JGJ
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, 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 (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 |
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| 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 |
| WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326) | Wiener Laboratories Saic | 2001-11-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |