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FDA 510(k)

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401

K-Number: K061412 · 2007-03-23

ApplicantThermo Electron Corp.
Decision Date2007-03-23
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron Corp.. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K061412. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401?

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Thermo Electron Corp.. The 510(k) number is K061412.

When did THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 receive FDA 510(k) clearance?

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 received FDA 510(k) clearance on 2007-03-23, under 510(k) number K061412.

Who is the listed applicant for THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401?

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

What is the FDA product code for THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401?

The FDA product code for THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 is JFY.

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Official Source

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