AXSYM PROGESTERONE— 510(k) K955025

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K955025 for AXSYM PROGESTERONE, Substantially Equivalent on 1996-03-07. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1995-11-02
Decision date: 1996-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.