AUTION JET AJ-4270 URINE ANALYZER— 510(k) K030600
Substantially EquivalentInternational Remote Imaging Systems
FDA 510(k) clearance K030600 for AUTION JET AJ-4270 URINE ANALYZER, Substantially Equivalent on 2003-07-11. 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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