PICCOLO MAGNESIUM TEST SYSTEM
FDA 510(k) clearance K040115 · decided 2004-01-30
Clearance details
- K-number
- K040115
- Device name
- PICCOLO MAGNESIUM TEST SYSTEM
- Applicant
- Abaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-20
- Decision date
- 2004-01-30
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JGJ
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Union City, CA, US
- Third-party review
- No
- Expedited review
- No
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| VITALAB MAGNESIUM REAGENT (K040508) | Clinical Data, Inc. | 2004-03-08 |
| 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.