ANTI-CYTOKERATIN MONOCLONAL ANTIBODY— 510(k) K864893

Name: FDA 510(k) clearance K864893
Creator: U.S. Food and Drug Administration
Published: 1988-07-07

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K864893 for ANTI-CYTOKERATIN MONOCLONAL ANTIBODY, Substantially Equivalent on 1988-07-07. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LYE
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1986-12-15
Decision date: 1988-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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K881259 — MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL1988-10-12

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