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FDA 510(k)

BE-SURE

K-Number: K791609 · 1979-10-02

ApplicantBiologics Intl., Inc.
Decision Date1979-10-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BE-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1979-10-02 under 510(k) number K791609. 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 BE-SURE?

BE-SURE is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K791609.

When did BE-SURE receive FDA 510(k) clearance?

BE-SURE received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791609.

Who is the listed applicant for BE-SURE?

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

What is the FDA product code for BE-SURE?

The FDA product code for BE-SURE is JHJ.

Other records listing Biologics Intl., Inc. 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.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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