XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
FDA 510(k) clearance K130915 · decided 2014-05-15
Clearance details
- K-number
- K130915
- Device name
- XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- Applicant
- Jas Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-02
- Decision date
- 2014-05-15
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.