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FDA 510(k)

GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM

K-Number: K991156 · 1999-05-28

ApplicantGreat Smokies Diagnostic Laboratory
Decision Date1999-05-28
Product CodeJOC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Great Smokies Diagnostic Laboratory. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K991156. The device is classified under product code JOC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM?

GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Great Smokies Diagnostic Laboratory. The 510(k) number is K991156.

When did GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM receive FDA 510(k) clearance?

GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM received FDA 510(k) clearance on 1999-05-28, under 510(k) number K991156.

Who is the listed applicant for GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM?

The FDA 510(k) record lists Great Smokies Diagnostic Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM?

The FDA product code for GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM is JOC.

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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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