FOLLICLE STIMULATING HORMONE-EIA-XT— 510(k) K896864

Name: FDA 510(k) clearance K896864
Creator: U.S. Food and Drug Administration
Published: 1990-01-11

Substantially Equivalent

In Vitro Diagnostics, Inc.

FDA 510(k) clearance K896864 for FOLLICLE STIMULATING HORMONE-EIA-XT, Substantially Equivalent on 1990-01-11. Applicant: In Vitro Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: In Vitro Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1989-12-06
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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K896867 — THYROID STIMULATING HORMONE-EIA-XT1990-02-23
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K896866 — LUTEINIZING HORMONE-EIA-XT1990-02-13
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