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FDA 510(k)

LUPO-TEST REGEANT

K-Number: K922326 · 1993-04-06

ApplicantGraoipore , Ltd.
Decision Date1993-04-06
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LUPO-TEST REGEANT is the device name listed in this FDA 510(k) record. The listed applicant is Graoipore , Ltd.. It received FDA 510(k) clearance on 1993-04-06 under 510(k) number K922326. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUPO-TEST REGEANT?

LUPO-TEST REGEANT is a medical device that received FDA 510(k) clearance on 1993-04-06. The listed applicant is Graoipore , Ltd.. The 510(k) number is K922326.

When did LUPO-TEST REGEANT receive FDA 510(k) clearance?

LUPO-TEST REGEANT received FDA 510(k) clearance on 1993-04-06, under 510(k) number K922326.

Who is the listed applicant for LUPO-TEST REGEANT?

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

What is the FDA product code for LUPO-TEST REGEANT?

The FDA product code for LUPO-TEST REGEANT is GIR.

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Related Devices (Code: GIR)

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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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