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FDA 510(k)

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

K-Number: K123127 · 2013-06-14

ApplicantMaine Standards Co.
Decision Date2013-06-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 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 2013-06-14 under 510(k) number K123127. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406?

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Maine Standards Co.. The 510(k) number is K123127.

When did VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 receive FDA 510(k) clearance?

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 received FDA 510(k) clearance on 2013-06-14, under 510(k) number K123127.

Who is the listed applicant for VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406?

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 PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406?

The FDA product code for VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 is JJX.

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Other records listing Maine Standards Co. as applicant

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Related Devices (Code: JJX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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