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510(k) K240468

Alkaline Phosphatase by Abbott Laboratories Diagnostics Division — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2024
Date Received
February 20, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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  • K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 (January 25, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)
  • K113269 — ELITTECH CLINICAL SYSTEMS ALP IFCC SL (December 29, 2011)