STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS— 510(k) K853548
Substantially EquivalentAmerican Dade
FDA 510(k) clearance K853548 for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS, Substantially Equivalent on 1985-09-18. Applicant: American Dade. Device class: Unclassified.
Clearance details
- Applicant
- American Dade
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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