SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT— 510(k) K942638

Name: FDA 510(k) clearance K942638
Creator: U.S. Food and Drug Administration
Published: 1994-09-07

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K942638 for SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT, Substantially Equivalent on 1994-09-07. 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: 1994-06-03
Decision date: 1994-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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