LCX NEISSERIA GONORRHOEAE ASSAY— 510(k) K935833

Name: FDA 510(k) clearance K935833
Creator: U.S. Food and Drug Administration
Published: 1996-05-06

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K935833 for LCX NEISSERIA GONORRHOEAE ASSAY, Substantially Equivalent on 1996-05-06. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LSL
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1993-12-07
Decision date: 1996-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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