AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL— 510(k) K121456
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K121456 for AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL, Substantially Equivalent on 2013-02-01. Applicant: Arkray, Inc..
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code KQO
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.