NICHOLS APO B CHEMILUMINESCENCE ASSAY— 510(k) K925702

Name: FDA 510(k) clearance K925702
Creator: U.S. Food and Drug Administration
Published: 1992-12-23

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K925702 for NICHOLS APO B CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1992-12-23. Applicant: Nichols Institute Diagnostics. Device class: 1.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1992-11-12
Decision date: 1992-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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