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FDA 510(k)

GASTROCCULT TM

K-Number: K821884 · 1982-10-08

ApplicantSmithkline Diagnostics, Inc.
Decision Date1982-10-08
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GASTROCCULT TM 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 1982-10-08 under 510(k) number K821884. 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 GASTROCCULT TM?

GASTROCCULT TM is a medical device that received FDA 510(k) clearance on 1982-10-08. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K821884.

When did GASTROCCULT TM receive FDA 510(k) clearance?

GASTROCCULT TM received FDA 510(k) clearance on 1982-10-08, under 510(k) number K821884.

Who is the listed applicant for GASTROCCULT TM?

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 GASTROCCULT TM?

The FDA product code for GASTROCCULT TM is KHE.

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Other records listing Smithkline Diagnostics, Inc. as applicant

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Related Devices (Code: 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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