CHEMILUMINESCENCE DHEA-S IMMUNOASSAY— 510(k) K931601

Name: FDA 510(k) clearance K931601
Creator: U.S. Food and Drug Administration
Published: 1993-07-27

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K931601 for CHEMILUMINESCENCE DHEA-S IMMUNOASSAY, Substantially Equivalent on 1993-07-27. Applicant: Nichols Institute. Device class: 1.

Clearance details

Applicant: Nichols Institute
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1993-04-01
Decision date: 1993-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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