IQ ALKALINE PHOSPHATASE— 510(k) K880344

Name: FDA 510(k) clearance K880344
Creator: U.S. Food and Drug Administration
Published: 1988-03-01

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K880344 for IQ ALKALINE PHOSPHATASE, Substantially Equivalent on 1988-03-01. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CJK
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1988-01-26
Decision date: 1988-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

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