AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM— 510(k) K093098
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K093098 for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM, Substantially Equivalent on 2009-12-23. Applicant: Arkray, Inc.. Device class: 1.
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Richardson, TX, US
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More clearances from Arkray, Inc.
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