LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST— 510(k) K894279

Name: FDA 510(k) clearance K894279
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K894279 for LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST, Substantially Equivalent on 1989-08-15. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1989-06-23
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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