AUTION MAX AX-4280 URINALYSIS SYSTEM— 510(k) K013783
Substantially EquivalentInternational Remote Imaging Systems
FDA 510(k) clearance K013783 for AUTION MAX AX-4280 URINALYSIS SYSTEM, Substantially Equivalent on 2002-01-18. Applicant: International Remote Imaging Systems. Device class: 1.
Clearance details
- Applicant
- International Remote Imaging Systems
- 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
- Traditional
- Location
- North Attleboro, MA, US
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More clearances from International Remote Imaging Systems
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