MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM— 510(k) K881439

Name: FDA 510(k) clearance K881439
Creator: U.S. Food and Drug Administration
Published: 1988-04-28

Substantially Equivalent

Los Alamos Diagnostics

FDA 510(k) clearance K881439 for MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM, Substantially Equivalent on 1988-04-28. 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: 1988-04-05
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamos, NM, US

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