DeviceClearance

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD— 510(k) K073604

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K073604 for DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD, Substantially Equivalent on 2008-03-13. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code CEC
Device class
Class 2
Regulation
21 CFR 862.1695
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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More clearances from Dade Behring, Inc.

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Adverse events under product code CEC

product code CEC
Malfunction
899
Total
899

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K073604

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 K073604.

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