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FDA 510(k)

AP3600 Automated Instrument

K-Number: K182793 · 2019-03-19

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2019-03-19
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AP3600 Automated Instrument is a medical device manufactured by Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-19 under approval number K182793. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AP3600 Automated Instrument?

AP3600 Automated Instrument is a medical device that received FDA 510(k) clearance on 2019-03-19. It is manufactured by Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K182793.

When was AP3600 Automated Instrument approved by the FDA?

AP3600 Automated Instrument received FDA 510(k) clearance on 2019-03-19, under approval number K182793.

What company makes AP3600 Automated Instrument?

AP3600 Automated Instrument is manufactured by Hitachi Chemical Diagnostics, Inc..

What is the FDA product code for AP3600 Automated Instrument?

The FDA product code for AP3600 Automated Instrument is DHB.

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Official Source

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