YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU— 510(k) K914256
Substantially EquivalentIntl. Remote Imaging Systems
FDA 510(k) clearance K914256 for YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU, Substantially Equivalent on 1992-05-01. Applicant: Intl. Remote Imaging Systems. Device class: 2.
Clearance details
- Applicant
- Intl. Remote Imaging Systems
- Product code
- Code GKL
- 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 GKL
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