939UDX URINE PATHOLOGY SYSTEM— 510(k) K000373
Substantially EquivalentIntl. Remote Imaging Systems
FDA 510(k) clearance K000373 for 939UDX URINE PATHOLOGY SYSTEM, Substantially Equivalent on 2000-04-14. Applicant: Intl. Remote Imaging Systems. Device class: 2.
Clearance details
- Applicant
- Intl. Remote Imaging Systems
- Product code
- Code LKM
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chatsworth, CA, US
Recent devices under product code LKM
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