COAT-A-COUNT NO-EXTRACTION ALDOSTERONE— 510(k) K831178
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K831178 for COAT-A-COUNT NO-EXTRACTION ALDOSTERONE, Substantially Equivalent on 1983-05-27. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code CJM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1045
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Diagnostic Products Corp.
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- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- 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.