510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010061Substantially Equivalent

Dimension Clinical Chemistry System, Model Xpand

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010061 is the FDA 510(k) clearance record for DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND, a class II device, cleared for Dade Behring, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K010061.

Clearance record

Decision date
Received
(65 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dade Behring, Inc. Glasgow Business Community;, P.O. Box 6101, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code CEM

Trailing 12 months
1 clearance under product code CEM in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CEM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260