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510(k) K162275

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

K162275 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "Randox RX Daytona Plus Alkaline Phosphatase (ALP)". The FDA issued a decision of Substantially Equivalent on April 21, 2017. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.

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

Other clearances by Randox Laboratories Limited

  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (October 5, 2023)
  • K221550 — Evidence MultiSTAT DOA Urine MultiPlex (October 5, 2023)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • K150819 — Triglycerides (August 6, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142181 — RANDOX ALDOLASE CALIBRATION SERUM (September 18, 2014)
  • K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY P (May 22, 2014)

Other clearances for product code CJE

  • K251074 — Tru Liver Health Test Panel (December 19, 2025)
  • K240468 — Alkaline Phosphatase (October 16, 2024)
  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • 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)

FDA data resources