FDA 510(k)

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER

K-Number: K070531 · 2007-09-04

Decision Date2007-09-04

Product CodeCGZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2007-09-04 under 510(k) number K070531. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER?

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2007-09-04. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K070531.

When did ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 2007-09-04, under 510(k) number K070531.

Who is the listed applicant for ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER?

The FDA product code for ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER is CGZ.

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Official Source

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