DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516— 510(k) K062191
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K062191 for DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516, Substantially Equivalent on 2006-08-21. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.