HUMAN GROWTH HORMONE IMMUNOASSAY KIT— 510(k) K961678

Name: FDA 510(k) clearance K961678
Creator: U.S. Food and Drug Administration
Published: 1996-07-08

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K961678 for HUMAN GROWTH HORMONE IMMUNOASSAY KIT, Substantially Equivalent on 1996-07-08. Applicant: Nichols Institute Diagnostics. Device class: 1.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1996-05-01
Decision date: 1996-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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