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FDA 510(k)

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005

K-Number: K012122 · 2001-08-20

ApplicantMaine Standards Co.
Decision Date2001-08-20
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 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 2001-08-20 under 510(k) number K012122. 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 CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005?

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 is a medical device that received FDA 510(k) clearance on 2001-08-20. The listed applicant is Maine Standards Co.. The 510(k) number is K012122.

When did VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 receive FDA 510(k) clearance?

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 received FDA 510(k) clearance on 2001-08-20, under 510(k) number K012122.

Who is the listed applicant for VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005?

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 CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005?

The FDA product code for VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 is 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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