PICCOLO MAGNESIUM TEST SYSTEM
FDA 510(k) clearance K091910 · decided 2009-10-01
Clearance details
- K-number
- K091910
- Device name
- PICCOLO MAGNESIUM TEST SYSTEM
- Applicant
- Abaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-25
- Decision date
- 2009-10-01
- Days to decision
- 98 days
- Clearance type
- Special
- 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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| ATAC PAK MAGNESIUM REAGENT (K030010) | Elan Diagnostics | 2003-03-10 |
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Recalls involving this device
No recalls on record reference this clearance.