SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY— 510(k) K893605

Name: FDA 510(k) clearance K893605
Creator: U.S. Food and Drug Administration
Published: 1989-06-20

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K893605 for SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1989-06-20. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1989-05-10
Decision date: 1989-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

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