DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32— 510(k) K081731

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code CGS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2008-06-19

Decision date

2008-08-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newark, DE, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081731.