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FDA 510(k)

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

K-Number: K100031 · 2010-07-19

ApplicantInd Diagnostic, Inc.
Decision Date2010-07-19
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2010-07-19 under 510(k) number K100031. 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 IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10?

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 is a medical device that received FDA 510(k) clearance on 2010-07-19. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K100031.

When did IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 receive FDA 510(k) clearance?

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 received FDA 510(k) clearance on 2010-07-19, under 510(k) number K100031.

Who is the listed applicant for IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10?

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

What is the FDA product code for IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10?

The FDA product code for IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 is KHE.

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Other records listing Ind Diagnostic, Inc. as applicant

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Related Devices (Code: KHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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