UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY— 510(k) K963116
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K963116 for UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY, Substantially Equivalent on 1996-08-20. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code JMO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E.I., CA
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