NATURAL DETECTOR SYSTEM— 510(k) K861731

Name: FDA 510(k) clearance K861731
Creator: U.S. Food and Drug Administration
Published: 1986-11-06

Substantially Equivalent

U.S. Health Resources Corp.

FDA 510(k) clearance K861731 for NATURAL DETECTOR SYSTEM, Substantially Equivalent on 1986-11-06. Applicant: U.S. Health Resources Corp.. Device class: 2.

Clearance details

Applicant: U.S. Health Resources Corp.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1986-05-06
Decision date: 1986-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K861452 — MONOSTAR SYSTEM: IM LATEX TEST1986-05-13

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