AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
FDA 510(k) clearance K121456 · decided 2013-02-01
Clearance details
- K-number
- K121456
- Device name
- AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
- Applicant
- Arkray, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-16
- Decision date
- 2013-02-01
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.