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FDA 510(k)

PREG-BETA ONE HOUR TUBE TEST

K-Number: K841853 · 1984-06-22

ApplicantIntl. Diagnostic, Inc.
Decision Date1984-06-22
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG-BETA ONE HOUR TUBE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841853. 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 PREG-BETA ONE HOUR TUBE TEST?

PREG-BETA ONE HOUR TUBE TEST is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K841853.

When did PREG-BETA ONE HOUR TUBE TEST receive FDA 510(k) clearance?

PREG-BETA ONE HOUR TUBE TEST received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841853.

Who is the listed applicant for PREG-BETA ONE HOUR TUBE TEST?

The FDA 510(k) record lists Intl. Diagnostic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREG-BETA ONE HOUR TUBE TEST?

The FDA product code for PREG-BETA ONE HOUR TUBE TEST is JHJ.

Other records listing Intl. Diagnostic, 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.

K840833PREG BETA BLUS SLIDEK834584NABI CRP-Q.S. TESTK840005NABI RF-Q.S. TESTK802343PREGNA B-ANTI HUMAN CHORIONIC GONADOTROK780321PREGNANCY TEST KIT, OVER-THE-COUNTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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