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FDA 510(k)

ACCUTEX BETA-HCG TEST

K-Number: K926112 · 1993-07-28

ApplicantJ.S. Medical Assoc.
Decision Date1993-07-28
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUTEX BETA-HCG TEST is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K926112. 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 ACCUTEX BETA-HCG TEST?

ACCUTEX BETA-HCG TEST is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K926112.

When did ACCUTEX BETA-HCG TEST receive FDA 510(k) clearance?

ACCUTEX BETA-HCG TEST received FDA 510(k) clearance on 1993-07-28, under 510(k) number K926112.

Who is the listed applicant for ACCUTEX BETA-HCG TEST?

The FDA 510(k) record lists J.S. Medical Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUTEX BETA-HCG TEST?

The FDA product code for ACCUTEX BETA-HCG TEST is JHJ.

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Other records listing J.S. Medical Assoc. as applicant

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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.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.K910946CLEARVIEW HCGUnipath , Ltd.

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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