FDA 510(k)

ADAMS A1c HA-8180V, CALIBRATOR 80

K-Number: K162822 · 2017-06-29

Decision Date2017-06-29

Product CodePDJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ADAMS A1c HA-8180V, CALIBRATOR 80 is a medical device manufactured by Arkray Factory, Inc.. It received FDA 510(k) clearance on 2017-06-29 under approval 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. It is manufactured by Arkray Factory, Inc.. The 510(k) number is K162822.

When was ADAMS A1c HA-8180V, CALIBRATOR 80 approved by the FDA?

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

What company makes ADAMS A1c HA-8180V, CALIBRATOR 80?

ADAMS A1c HA-8180V, CALIBRATOR 80 is manufactured by Arkray Factory, Inc..

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.

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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.