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FDA 510(k)

OREIA-Q-TY, ENZYME IMMUNOASSAY

K-Number: K802693 · 1980-12-10

ApplicantOrganon, Inc.
Decision Date1980-12-10
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OREIA-Q-TY, ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802693. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREIA-Q-TY, ENZYME IMMUNOASSAY?

OREIA-Q-TY, ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Organon, Inc.. The 510(k) number is K802693.

When did OREIA-Q-TY, ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

OREIA-Q-TY, ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802693.

Who is the listed applicant for OREIA-Q-TY, ENZYME IMMUNOASSAY?

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 OREIA-Q-TY, ENZYME IMMUNOASSAY?

The FDA product code for OREIA-Q-TY, ENZYME IMMUNOASSAY is KLI.

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Other records listing Organon, Inc. as applicant

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.

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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