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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 the device name listed in this FDA 510(k) record. The listed applicant is Diatron U.S., Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) 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. The listed applicant is Diatron U.S., Inc.. The 510(k) number is K151487.

When did Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method receive FDA 510(k) clearance?

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

Who is the listed applicant for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

The FDA 510(k) record lists Diatron U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: CFR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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