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FDA 510(k)

ADAMS A1c HA-8180V, CALIBRATOR 80

K-Number: K162822 · 2017-06-29

ApplicantArkray Factory, Inc.
Decision Date2017-06-29
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADAMS A1c HA-8180V, CALIBRATOR 80 is the device name listed in this FDA 510(k) record. The listed applicant is Arkray Factory, Inc.. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K162822. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAMS A1c HA-8180V, CALIBRATOR 80?

ADAMS A1c HA-8180V, CALIBRATOR 80 is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Arkray Factory, Inc.. The 510(k) number is K162822.

When did ADAMS A1c HA-8180V, CALIBRATOR 80 receive FDA 510(k) clearance?

ADAMS A1c HA-8180V, CALIBRATOR 80 received FDA 510(k) clearance on 2017-06-29, under 510(k) number K162822.

Who is the listed applicant for ADAMS A1c HA-8180V, CALIBRATOR 80?

The FDA 510(k) record lists Arkray Factory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAMS A1c HA-8180V, CALIBRATOR 80?

The FDA product code for ADAMS A1c HA-8180V, CALIBRATOR 80 is PDJ.

Other records listing Arkray Factory, Inc. as applicant

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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.

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