FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
K Number: K121456
·
Decision Feb 1, 2013
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
45
Applicant Total
18
Review Days
261
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
- K Number
- K121456
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arkray, Inc.
- Date Received
- May 16, 2012
- Decision Date
- February 1, 2013
- Product Code
- KQO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KQO | Automated Urinalysis System | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQO), ordered by most recent decision date.
URISCAN OPTIMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CYBOW READER, MODELS 300 & 720
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URITEST 50 AND URITEST 500 URINE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Arkray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | May 3, 2024 | Substantially Equivalent |
| K193514 | AUTION MAX AX-4060 Urinalysis System | Apr 13, 2023 | Substantially Equivalent |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Oct 17, 2022 | Substantially Equivalent |
| K200788 | Assure Titanium Blood Glucose Monitoring System | May 23, 2022 | Substantially Equivalent |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Oct 7, 2016 | Substantially Equivalent |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Dec 23, 2009 | Substantially Equivalent |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Mar 24, 2006 | Substantially Equivalent |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Jan 31, 2006 | Substantially Equivalent |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Jun 17, 2005 | Substantially Equivalent |
| K050790 | SPOTCHEM II LDH TEST | Jun 6, 2005 | Substantially Equivalent |