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510(k) K171080

ALP IFCC Gen.2 by Roche Diagnostics Operations (Rdo) — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2017
Date Received
April 11, 2017
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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  • K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (December 19, 2016)
  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
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Other clearances for product code CJE

  • K251074 — Tru Liver Health Test Panel (December 19, 2025)
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  • 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)
  • 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)