FDA 510(k)

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

K-Number: K110880 · 2011-07-05

Decision Date2011-07-05

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Company, LLC. It received FDA 510(k) clearance on 2011-07-05 under 510(k) number K110880. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT?

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT is a medical device that received FDA 510(k) clearance on 2011-07-05. The listed applicant is Maine Standards Company, LLC. The 510(k) number is K110880.

When did VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT receive FDA 510(k) clearance?

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT received FDA 510(k) clearance on 2011-07-05, under 510(k) number K110880.

Who is the listed applicant for VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT?

The FDA 510(k) record lists Maine Standards Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT?

The FDA product code for VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT is JJY.

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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.