STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-— 510(k) K831177
Substantially EquivalentAmerican Dade
FDA 510(k) clearance K831177 for STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-, Substantially Equivalent on 1983-05-17. Applicant: American Dade. Device class: 2.
Clearance details
- Applicant
- American Dade
- Product code
- Code KXT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from American Dade
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