ENZYMUN TEST(R) DIGOXIN— 510(k) K901216
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K901216 for ENZYMUN TEST(R) DIGOXIN, Substantially Equivalent on 1990-05-31. 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
- Indianapolis, IN, US
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More clearances from Boehringer Mannheim Corp.
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