ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.— 510(k) K881123

Name: FDA 510(k) clearance K881123
Creator: U.S. Food and Drug Administration
Published: 1988-04-28

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K881123 for ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO., Substantially Equivalent on 1988-04-28. Applicant: Nichols Institute Diagnostics. Device class: 1.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1988-03-16
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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