Atellica CH Magnesium (Mg)
FDA 510(k) clearance K162399 · decided 2017-01-19
Clearance details
- K-number
- K162399
- Device name
- Atellica CH Magnesium (Mg)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-26
- Decision date
- 2017-01-19
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- JGJ
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
|---|---|---|
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |