COAT-A-COUNT NEONATAL T4 KIT RIA KIT— 510(k) K831107
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K831107 for COAT-A-COUNT NEONATAL T4 KIT RIA KIT, Substantially Equivalent on 1983-05-18. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.