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FDA 510(k)

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

K-Number: K151487 · 2016-01-14

ApplicantDiatron U.S., Inc.
Decision Date2016-01-14
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is a medical device manufactured by Diatron U.S., Inc.. It received FDA 510(k) clearance on 2016-01-14 under approval number K151487. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Diatron U.S., Inc.. The 510(k) number is K151487.

When was Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method approved by the FDA?

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method received FDA 510(k) clearance on 2016-01-14, under approval number K151487.

What company makes Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is manufactured by Diatron U.S., Inc..

What is the FDA product code for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

The FDA product code for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is CFR.

Related Clinical Trials

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Related PubMed Literature

PMID: 42208661 A FeAsibility items Checklist for assessing implementation characTeristics of patient reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): development and evaluation. Clinical medicine (London, England) (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026) PMID: 40982375 Test Method Development for Cleaning Chemistry Performance Determination. Biomedical instrumentation & technology (2025) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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