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510(k) K162275

Randox RX Daytona Plus Alkaline Phosphatase (ALP) by Randox Laboratories Limited — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2017
Date Received
August 12, 2016
Clearance Type
Traditional
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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Other clearances for product code CJE

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  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 (January 25, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 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)