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510(k) K122323

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI by Siemens Healthcare Diagnostics — Product Code CJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2012
Date Received
August 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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Other clearances for product code CJO

  • K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPH (July 23, 2012)
  • K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (January 29, 1999)
  • K770155 — ALKALINE PHOSPHATASE ISOYZME REAGENT SET (January 31, 1977)