GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY— 510(k) K850410

Name: FDA 510(k) clearance K850410
Creator: U.S. Food and Drug Administration
Published: 1985-05-08

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K850410 for GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY, Substantially Equivalent on 1985-05-08. Applicant: Warner-Lambert Co.. Device class: 1.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
Advisory panel: Immunology
Date received: 1985-02-04
Decision date: 1985-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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