EASYTOUCH HEMOGLOBIN REAGENT— 510(k) K832750

Name: FDA 510(k) clearance K832750
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Worthington Diagnostic Systems

FDA 510(k) clearance K832750 for EASYTOUCH HEMOGLOBIN REAGENT, Substantially Equivalent on 1983-09-26. Applicant: Worthington Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Worthington Diagnostic Systems
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1983-08-15
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KHG

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K001462 — CARESIDE HEMOGLOBIN2000-08-21

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K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE1984-01-04
K832427 — EASYTOUCH TROMBOPLASTIN REAGENT1983-10-14
K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN1983-10-14
K832749 — EASYTOUCH BUN REAGENT SET1983-10-14
K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT1983-10-14

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