TIA-IGM REAGENT & CALIBRATOR SETS— 510(k) K831103
Substantially EquivalentWorthington Diagnostic Systems
FDA 510(k) clearance K831103 for TIA-IGM REAGENT & CALIBRATOR SETS, Substantially Equivalent on 1983-04-27. Applicant: Worthington Diagnostic Systems. Device class: 2.
Clearance details
- Applicant
- Worthington Diagnostic Systems
- Product code
- Code DFT
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DFT
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