ELECSYS DIGOXIN— 510(k) K973112
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K973112 for ELECSYS DIGOXIN, Substantially Equivalent on 1997-10-10. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- 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
- Concord, CA, US
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More clearances from Boehringer Mannheim Corp.
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