AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144— 510(k) K884100

Name: FDA 510(k) clearance K884100
Creator: U.S. Food and Drug Administration
Published: 1988-11-10

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K884100 for AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144, Substantially Equivalent on 1988-11-10. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1988-09-28
Decision date: 1988-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, 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.