PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
FDA 510(k) clearance K950164 · decided 1995-04-13
Clearance details
- K-number
- K950164
- Device name
- PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
- Applicant
- Abaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1995-04-13
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry recall (Z-1066-2011) | Abaxis, Incorporated | 2011-02-09 |