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FDA 510(k)

IMMUSTAPH LATEX AGGLUTINATION KIT

K-Number: K842709 · 1984-08-03

ApplicantImmucell Corp.
Decision Date1984-08-03
Product CodeLHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUSTAPH LATEX AGGLUTINATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immucell Corp.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K842709. The device is classified under product code LHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUSTAPH LATEX AGGLUTINATION KIT?

IMMUSTAPH LATEX AGGLUTINATION KIT is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Immucell Corp.. The 510(k) number is K842709.

When did IMMUSTAPH LATEX AGGLUTINATION KIT receive FDA 510(k) clearance?

IMMUSTAPH LATEX AGGLUTINATION KIT received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842709.

Who is the listed applicant for IMMUSTAPH LATEX AGGLUTINATION KIT?

The FDA 510(k) record lists Immucell Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUSTAPH LATEX AGGLUTINATION KIT?

The FDA product code for IMMUSTAPH LATEX AGGLUTINATION KIT is LHJ.

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Related Devices (Code: LHJ)

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.

K940557STAPHYTECT-ODUnipath , Ltd.K812181STAPHYLOCOCCAL PROTEIN A INSOLUBLEOxoid U.S.A., 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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