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FDA 510(k)

HEMOCCULT ICT

K-Number: K080812 · 2008-06-25

ApplicantBeckman Coulter, Inc.
Decision Date2008-06-25
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCCULT ICT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K080812. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCCULT ICT?

HEMOCCULT ICT is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K080812.

When did HEMOCCULT ICT receive FDA 510(k) clearance?

HEMOCCULT ICT received FDA 510(k) clearance on 2008-06-25, under 510(k) number K080812.

Who is the listed applicant for HEMOCCULT ICT?

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

What is the FDA product code for HEMOCCULT ICT?

The FDA product code for HEMOCCULT ICT is KHE.

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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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