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FDA 510(k)

FHT (FECAL HEME TEST)

K-Number: K905782 · 1991-05-06

ApplicantAerscher, Inc.
Decision Date1991-05-06
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FHT (FECAL HEME TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Aerscher, Inc.. It received FDA 510(k) clearance on 1991-05-06 under 510(k) number K905782. 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 FHT (FECAL HEME TEST)?

FHT (FECAL HEME TEST) is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Aerscher, Inc.. The 510(k) number is K905782.

When did FHT (FECAL HEME TEST) receive FDA 510(k) clearance?

FHT (FECAL HEME TEST) received FDA 510(k) clearance on 1991-05-06, under 510(k) number K905782.

Who is the listed applicant for FHT (FECAL HEME TEST)?

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

What is the FDA product code for FHT (FECAL HEME TEST)?

The FDA product code for FHT (FECAL HEME TEST) is KHE.

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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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