NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT— 510(k) K964635

Name: FDA 510(k) clearance K964635
Creator: U.S. Food and Drug Administration
Published: 1997-05-21

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K964635 for NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT, Substantially Equivalent on 1997-05-21. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
Advisory panel: Clinical Chemistry
Date received: 1996-11-19
Decision date: 1997-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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