IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT— 510(k) K983151
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K983151 for IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT, Substantially Equivalent on 1998-11-05. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- 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
- Brea, CA, US
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More clearances from Beckman Coulter, Inc.
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