TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II— 510(k) K940817

Name: FDA 510(k) clearance K940817
Creator: U.S. Food and Drug Administration
Published: 1995-02-08

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K940817 for TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II, Substantially Equivalent on 1995-02-08. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JHF
Device class: Class 2
Regulation: 21 CFR 862.1455
Advisory panel: Clinical Chemistry
Date received: 1994-02-22
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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