AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT— 510(k) K893469

Name: FDA 510(k) clearance K893469
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K893469 for AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT, Substantially Equivalent on 1989-08-15. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1989-05-04
Decision date: 1989-08-15
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.