PICCOLO LACTATE TEST SYSTEM— 510(k) K130113
Substantially EquivalentAbaxis, Inc.
FDA 510(k) clearance K130113 for PICCOLO LACTATE TEST SYSTEM, Substantially Equivalent on 2013-03-11. Applicant: Abaxis, Inc.. Device class: 1.
Clearance details
- Applicant
- Abaxis, Inc.
- Product code
- Code KHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1450
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
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More clearances from Abaxis, Inc.
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