IMMUSTAPH LATEX AGGLUTINATION KIT— 510(k) K842709

Name: FDA 510(k) clearance K842709
Creator: U.S. Food and Drug Administration
Published: 1984-08-03

Substantially Equivalent

Immucell Corp.

FDA 510(k) clearance K842709 for IMMUSTAPH LATEX AGGLUTINATION KIT, Substantially Equivalent on 1984-08-03. Applicant: Immucell Corp.. Device class: 1.

Clearance details

Applicant: Immucell Corp.
Product code: Code LHJ
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1984-07-12
Decision date: 1984-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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