AXSYM FOLLICLE STIMULATING HORMONE (FSH)— 510(k) K935612

Name: FDA 510(k) clearance K935612
Creator: U.S. Food and Drug Administration
Published: 1994-06-21

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K935612 for AXSYM FOLLICLE STIMULATING HORMONE (FSH), Substantially Equivalent on 1994-06-21. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1993-11-22
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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