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FDA 510(k), K091216, CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
FDA 510(k), K091216, CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
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510(K) Number: K091216
Device Name: CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
Manufacturer: NOOR MALKI
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: JIL
Classification Product Code: KXA
Date Received: 04/27/2009
Decision Date: 10/09/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
Manufacturer: NOOR MALKI
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: JIL
Classification Product Code: KXA
Date Received: 04/27/2009
Decision Date: 10/09/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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