SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC— 510(k) K800672
Substantially EquivalentDiagnostic Solutions, Inc.
FDA 510(k) clearance K800672 for SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC, Substantially Equivalent on 1980-05-28. Applicant: Diagnostic Solutions, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Solutions, Inc.
- Product code
- Code CDH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDH
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