DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)— 510(k) K061923
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K061923 for DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310), Substantially Equivalent on 2006-08-25. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K061923
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061923.
Data sourced from openFDA. This site is unofficial and independent of the FDA.