COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE— 510(k) K833708

Name: FDA 510(k) clearance K833708
Creator: U.S. Food and Drug Administration
Published: 1984-01-04

Substantially Equivalent

Worthington Diagnostic Systems

FDA 510(k) clearance K833708 for COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE, Substantially Equivalent on 1984-01-04. Applicant: Worthington Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Worthington Diagnostic Systems
Product code: Code LKZ
Device class: Class 2
Regulation: 21 CFR 864.7100
Advisory panel: Hematology
Date received: 1983-10-20
Decision date: 1984-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code LKZ

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K832771 — ERYTHROCYTE TEST1983-10-28

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K832749 — EASYTOUCH BUN REAGENT SET1983-10-14
K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT1983-10-14
K832750 — EASYTOUCH HEMOGLOBIN REAGENT1983-09-26

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