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FDA 510(k)

ACCURATE BETA

K-Number: K812967 · 1981-11-06

ApplicantOrganon, Inc.
Decision Date1981-11-06
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCURATE BETA is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812967. 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 ACCURATE BETA?

ACCURATE BETA is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Organon, Inc.. The 510(k) number is K812967.

When did ACCURATE BETA receive FDA 510(k) clearance?

ACCURATE BETA received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812967.

Who is the listed applicant for ACCURATE BETA?

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 ACCURATE BETA?

The FDA product code for ACCURATE BETA 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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