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FDA 510(k)

RUBENOSTICON

K-Number: K780063 · 1978-01-20

ApplicantOrganon, Inc.
Decision Date1978-01-20
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBENOSTICON is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780063. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBENOSTICON?

RUBENOSTICON is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Organon, Inc.. The 510(k) number is K780063.

When did RUBENOSTICON receive FDA 510(k) clearance?

RUBENOSTICON received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780063.

Who is the listed applicant for RUBENOSTICON?

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 RUBENOSTICON?

The FDA product code for RUBENOSTICON is GOK.

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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: GOK)

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.

K832228RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems PreanalyticK810835RUBAZYME - MAbbott LaboratoriesK792635ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.K792133RUBELISA TEST KITMicrobiological Assoc.K790122RUBANONOrganon, Inc.K781638RUBINDEX*DIRECT SYSTEMOrtho Diagnostics, 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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