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FDA 510(k)

NEO-PREGNOSTICON DUOCLON TUBE TEST

K-Number: K831339 · 1983-06-08

ApplicantOrganon, Inc.
Decision Date1983-06-08
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEO-PREGNOSTICON DUOCLON TUBE 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 1983-06-08 under 510(k) number K831339. 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 NEO-PREGNOSTICON DUOCLON TUBE TEST?

NEO-PREGNOSTICON DUOCLON TUBE TEST is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Organon, Inc.. The 510(k) number is K831339.

When did NEO-PREGNOSTICON DUOCLON TUBE TEST receive FDA 510(k) clearance?

NEO-PREGNOSTICON DUOCLON TUBE TEST received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831339.

Who is the listed applicant for NEO-PREGNOSTICON DUOCLON TUBE 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 NEO-PREGNOSTICON DUOCLON TUBE TEST?

The FDA product code for NEO-PREGNOSTICON DUOCLON TUBE TEST is JHJ.

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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: 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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