DIMENSION IRON CALIBRATOR— 510(k) K060266

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K060266 for DIMENSION IRON CALIBRATOR, Substantially Equivalent on 2006-03-09. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code JIS
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
Download summary PDFView on FDA.gov ↗

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Recalls naming K060266

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060266.

Data sourced from openFDA. This site is unofficial and independent of the FDA.