APO A-1 CHEMILUMINESCENCE ASSAY— 510(k) K931777

Name: FDA 510(k) clearance K931777
Creator: U.S. Food and Drug Administration
Published: 1993-08-16

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K931777 for APO A-1 CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1993-08-16. Applicant: Nichols Institute. Device class: 1.

Clearance details

Applicant: Nichols Institute
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1993-04-09
Decision date: 1993-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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