NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT— 510(k) K962208

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K962208 for NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT, Substantially Equivalent on 1997-04-08. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant
Nichols Institute Diagnostics
Product code
Code CGR
Device class
Class 2
Regulation
21 CFR 862.1205
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Juan Capistrano, CA, US
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