PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM— 510(k) K051108
Substantially EquivalentAbaxis, Inc.
FDA 510(k) clearance K051108 for PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM, Substantially Equivalent on 2005-07-08. Applicant: Abaxis, Inc.. Device class: 2.
Clearance details
- Applicant
- Abaxis, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- 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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