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FDA 510(k)

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST

K-Number: K063693 · 2007-05-11

ApplicantNew Bay Bioresearch Co. , Ltd.
Decision Date2007-05-11
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is New Bay Bioresearch Co. , Ltd.. It received FDA 510(k) clearance on 2007-05-11 under 510(k) number K063693. 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 FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST?

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is New Bay Bioresearch Co. , Ltd.. The 510(k) number is K063693.

When did FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST receive FDA 510(k) clearance?

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST received FDA 510(k) clearance on 2007-05-11, under 510(k) number K063693.

Who is the listed applicant for FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST?

The FDA 510(k) record lists New Bay Bioresearch Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST?

The FDA product code for FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST is KHE.

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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

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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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