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FDA 510(k)

OREAI-Q-TU TEST

K-Number: K802464 · 1980-10-31

ApplicantOrganon, Inc.
Decision Date1980-10-31
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OREAI-Q-TU TEST is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802464. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREAI-Q-TU TEST?

OREAI-Q-TU TEST is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Organon, Inc.. The 510(k) number is K802464.

When did OREAI-Q-TU TEST receive FDA 510(k) clearance?

OREAI-Q-TU TEST received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802464.

Who is the listed applicant for OREAI-Q-TU TEST?

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

What is the FDA product code for OREAI-Q-TU TEST?

The FDA product code for OREAI-Q-TU TEST is KHQ.

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Other records listing Organon, 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.

K950861RECONSTITUTION ACCESSOREISK853388MONOSTICON UNI-DOTK842314DUOCLON COLOR-CEPTK841525OREIA II B-HCG PREGNANCY TEST KITK841602ACCURATE BETA 30 PREGNANCY TEST KITK840650B-NEOCEPT 30

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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