COAT-A-COUNT DIRECT ANDROSTENEDIONE— 510(k) K954755
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K954755 for COAT-A-COUNT DIRECT ANDROSTENEDIONE, Substantially Equivalent on 1995-11-29. Applicant: Diagnostic Products Corp.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code CIZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1075
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code CIZ
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Recalls naming K954755
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954755.
Data sourced from openFDA. This site is unofficial and independent of the FDA.