VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY— 510(k) K926422

Name: FDA 510(k) clearance K926422
Creator: U.S. Food and Drug Administration
Published: 1993-06-02

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K926422 for VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY, Substantially Equivalent on 1993-06-02. Applicant: Syva Co.. Device class: 1.

Clearance details

Applicant: Syva Co.
Product code: Code GGJ
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1992-12-23
Decision date: 1993-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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