Atlas FDA

CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

FDA 510(k) clearance K091216 · decided 2009-10-09

Clearance details

K-number
K091216
Device name
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-04-27
Decision date
2009-10-09
Days to decision
165 days
Clearance type
Traditional
Product code
JIL
Device class
2
Regulation number
862.1340
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Norowood, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems recall (Z-0081-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek recall (Z-0082-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare recall (Z-0083-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. recall (Z-1545-2014)Siemens Healthcare Diagnostics Inc2014-05-04

PMA approvals by this applicant

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