SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA— 510(k) K862439

Name: FDA 510(k) clearance K862439
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K862439 for SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA, Substantially Equivalent on 1986-08-19. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1986-06-26
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

Download summary PDF View on FDA.gov ↗

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