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Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

by Lite-On Technology Corp. H.S.P.B. 510(k)

Active United States

510(k) K171971

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171971 Date25 Jan 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CJE
Device Class
Class II
Regulation
21 CFR Part 862.1050
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It utilizes precision photometric measurement technology combined with single-use disposable reagent panel discs to measure the amount of substance in blood.

The device is supplied as a portable analyzer with single-use reagent panel discs. It is classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II under FDA 510(k) clearance K171971, and is intended for use in clinical chemistry testing.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Comprehensive Metabolic Panel skyla Minicare C300 Analyzer used for?

    It is used for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum, utilizing precision photometric measurement technology with single-use disposable reagent panel discs to measure the amount of substance in blood.

  • How is the Comprehensive Metabolic Panel skyla Minicare C300 Analyzer supplied and is it single-use or reusable?

    The device is supplied as a portable analyzer with single-use reagent panel discs; the analyzer is reusable while the reagent discs are single-use disposables, ensuring each test uses a fresh disc for accurate results.

  • What type of samples can be used with the Comprehensive Metabolic Panel skyla Minicare C300 Analyzer?

    It accepts lithium-heparinized venous whole blood, heparinized plasma, or serum samples for testing, as specified in its intended use for clinical chemistry analysis.

  • What regulatory pathway was used for the Comprehensive Metabolic Panel skyla Minicare C300 Analyzer?

    The device received FDA 510(k) clearance under K171971 and is classified as a Class II device with product code CJE for Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes.