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FDA 510(k)

RAPI-DOT

K-Number: K802974 · 1980-12-19

ApplicantOrganon, Inc.
Decision Date1980-12-19
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAPI-DOT is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802974. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPI-DOT?

RAPI-DOT is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Organon, Inc.. The 510(k) number is K802974.

When did RAPI-DOT receive FDA 510(k) clearance?

RAPI-DOT received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802974.

Who is the listed applicant for RAPI-DOT?

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 RAPI-DOT?

The FDA product code for RAPI-DOT is JHJ.

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: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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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