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FDA 510(k)

PREG BETA BLUS SLIDE

K-Number: K840833 · 1984-05-30

ApplicantIntl. Diagnostic, Inc.
Decision Date1984-05-30
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG BETA BLUS SLIDE 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 1984-05-30 under 510(k) number K840833. 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 BLUS SLIDE?

PREG BETA BLUS SLIDE is a medical device that received FDA 510(k) clearance on 1984-05-30. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K840833.

When did PREG BETA BLUS SLIDE receive FDA 510(k) clearance?

PREG BETA BLUS SLIDE received FDA 510(k) clearance on 1984-05-30, under 510(k) number K840833.

Who is the listed applicant for PREG BETA BLUS SLIDE?

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 BLUS SLIDE?

The FDA product code for PREG BETA BLUS SLIDE is JHJ.

Related Clinical Trials

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.

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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.

K841853PREG-BETA ONE HOUR TUBE TESTK834584NABI 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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