CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797— 510(k) K091216

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code JIL

Device class

Class 2

Regulation

21 CFR 862.1340

Advisory panel

Clinical Chemistry

Date received

2009-04-27

Decision date

2009-10-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Norowood, MA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091216.