3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE— 510(k) K912357
Substantially EquivalentR&D Systems, Inc.
FDA 510(k) clearance K912357 for 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE, Substantially Equivalent on 1991-07-09. Applicant: R&D Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- R&D Systems, Inc.
- Product code
- Code KRX
- Device class
- Class 2
- Regulation
- 21 CFR 864.8150
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code KRX
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