FDA 510(k)

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

K-Number: K083891 · 2009-03-23

Decision Date2009-03-23

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Co.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K083891. 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 THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901?

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Maine Standards Co.. The 510(k) number is K083891.

When did VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 receive FDA 510(k) clearance?

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 received FDA 510(k) clearance on 2009-03-23, under 510(k) number K083891.

Who is the listed applicant for VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901?

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

What is the FDA product code for VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901?

The FDA product code for VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 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.