510(k) K173294
- Device
- Magnesium
- Applicant
- Abbott Laboratories
- 510(k) number
- K173294
- Product code
- JGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-18
- Date received
- 2017-10-16
- Regulation
- 862.1495
- Classification name
- Photometric Method, Magnesium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kimberly Senseman
- Address
- 1921 Hurd Dr. Irving TX US 75038 75038
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 1218882
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 1832216
- 1319808
- 3009473156
- 8040374
- 3010939897
- 3002809144
- 1000403749
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3014607865
- 3004493545
- 2939693
- 3003593973
- 3016438761
- 3002642396
- 2050010
- 3010825766
- 2085064
- 1616487
- 9610126
- 1220972
- 1319681
- 3004438098
- 3000308930
- 3000148879
Source Documents#
Other 510(k) Records For Product Code JGJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181748 | Magnesium | Abbott Laboratories | 2018-09-12 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | 2017-04-28 |
| K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 |
| K122302 | ACE MAGNESIUM REGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| K111915 | MAGNESIUM ASSAY | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| K092737 | EASYRA MG REAGENT, MODEL 10220 | Medica Corp. | 2009-11-17 |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2009-10-01 |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Diagnostic Chemicals , Ltd. | 2007-01-19 |
| K040508 | VITALAB MAGNESIUM REAGENT | Clinical Data, Inc. | 2004-03-08 |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2004-01-30 |
| K030010 | ATAC PAK MAGNESIUM REAGENT | Elan Diagnostics | 2003-03-10 |
| K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 | Wiener Laboratories Saic | 2001-11-08 |
| K003835 | JAS MAGNESIUM REAGENT | Jas Diagnostics, Inc. | 2001-03-23 |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-09-02 |
| K991717 | CARESIDE MG | Careside, Inc. | 1999-08-10 |
Legacy Summary#
summary
FDA Review#
Decision Summary