NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS— 510(k) K972070

Name: FDA 510(k) clearance K972070
Creator: U.S. Food and Drug Administration
Published: 1997-06-26

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K972070 for NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS, Substantially Equivalent on 1997-06-26. Applicant: Nichols Institute Diagnostics. Device class: 1.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1997-06-03
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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