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FDA 510(k)

HEMOCCULT WIPE TEST

K-Number: K862849 · 1986-12-09

ApplicantSmithkline Diagnostics, Inc.
Decision Date1986-12-09
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCCULT WIPE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-12-09 under 510(k) number K862849. 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 WIPE TEST?

HEMOCCULT WIPE TEST is a medical device that received FDA 510(k) clearance on 1986-12-09. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K862849.

When did HEMOCCULT WIPE TEST receive FDA 510(k) clearance?

HEMOCCULT WIPE TEST received FDA 510(k) clearance on 1986-12-09, under 510(k) number K862849.

Who is the listed applicant for HEMOCCULT WIPE TEST?

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

What is the FDA product code for HEMOCCULT WIPE TEST?

The FDA product code for HEMOCCULT WIPE TEST is KHE.

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Other records listing Smithkline Diagnostics, Inc. as applicant

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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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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