UTISCREEN(R) BACTERIAL ATP TEST— 510(k) K864202

Name: FDA 510(k) clearance K864202
Creator: U.S. Food and Drug Administration
Published: 1987-02-13

Substantially Equivalent

Los Alamos Diagnostics

FDA 510(k) clearance K864202 for UTISCREEN(R) BACTERIAL ATP TEST, Substantially Equivalent on 1987-02-13. Applicant: Los Alamos Diagnostics. Device class: 1.

Clearance details

Applicant: Los Alamos Diagnostics
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1986-10-27
Decision date: 1987-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamos, NM, US

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