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FDA 510(k)

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO

K-Number: K802343 · 1980-10-10

ApplicantIntl. Diagnostic, Inc.
Decision Date1980-10-10
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO 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 1980-10-10 under 510(k) number K802343. 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 PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO?

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K802343.

When did PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO receive FDA 510(k) clearance?

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802343.

Who is the listed applicant for PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO?

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 PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO?

The FDA product code for PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO 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 TESTK840833PREG BETA BLUS SLIDEK834584NABI CRP-Q.S. TESTK840005NABI RF-Q.S. TESTK780321PREGNANCY 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

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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