CDS HEMATOLOGY CALIBRATOR (CDS CAL)— 510(k) K041130
Substantially EquivalentClinical Diagnostic Solutions, Inc.
FDA 510(k) clearance K041130 for CDS HEMATOLOGY CALIBRATOR (CDS CAL), Substantially Equivalent on 2004-06-10. Applicant: Clinical Diagnostic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Diagnostic Solutions, Inc.
- Product code
- Code KRZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.8165
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Plantation, FL, US
Recent devices under product code KRZ
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