DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE— 510(k) K061238

Clearance details

Applicant

Dade Behring, Inc.

Product code

Code KHS

Device class

Class 2

Regulation

21 CFR 862.1160

Advisory panel

Clinical Chemistry

Date received

2006-05-03

Decision date

2006-05-25

Decision

Substantially Equivalent

Clearance type

Special

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 K061238.