MONOSTAR SYSTEM: IM LATEX TEST— 510(k) K861452

Name: FDA 510(k) clearance K861452
Creator: U.S. Food and Drug Administration
Published: 1986-05-13

Substantially Equivalent

U.S. Health Resources Corp.

FDA 510(k) clearance K861452 for MONOSTAR SYSTEM: IM LATEX TEST, Substantially Equivalent on 1986-05-13. Applicant: U.S. Health Resources Corp.. Device class: 2.

Clearance details

Applicant: U.S. Health Resources Corp.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1986-04-18
Decision date: 1986-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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