COAT-A-COUNT NO-EXTRACTION TESTOSTERONE— 510(k) K831342
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K831342 for COAT-A-COUNT NO-EXTRACTION TESTOSTERONE, Substantially Equivalent on 1983-06-02. Applicant: Diagnostic Products Corp.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDZ
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- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.