HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY— 510(k) K862083

Name: FDA 510(k) clearance K862083
Creator: U.S. Food and Drug Administration
Published: 1986-07-02

Substantially Equivalent

Hygeia Sciences

FDA 510(k) clearance K862083 for HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY, Substantially Equivalent on 1986-07-02. Applicant: Hygeia Sciences. Device class: 2.

Clearance details

Applicant: Hygeia Sciences
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1986-06-02
Decision date: 1986-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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