VENOM TIEM REAGENT— 510(k) K955115
Substantially EquivalentMedical Diagnostic Technologies, Inc.
FDA 510(k) clearance K955115 for VENOM TIEM REAGENT, Substantially Equivalent on 1996-04-03. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Diagnostic Technologies, Inc.
- Product code
- Code JCO
- Device class
- Class 2
- Regulation
- 21 CFR 864.8100
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Recent devices under product code JCO
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