SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-— 510(k) K850239

Name: FDA 510(k) clearance K850239
Creator: U.S. Food and Drug Administration
Published: 1985-04-01

Substantially Equivalent

Toa Medical Electronics USA, Inc.

FDA 510(k) clearance K850239 for SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-, Substantially Equivalent on 1985-04-01. Applicant: Toa Medical Electronics USA, Inc.. Device class: 1.

Clearance details

Applicant: Toa Medical Electronics USA, Inc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1985-01-22
Decision date: 1985-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson, CA, US

Download summary PDF View on FDA.gov ↗

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K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

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K931149 — CA-1000 AUTOMATED COAGULATION ANALYZER1993-11-03
K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES1992-04-29
K914744 — SYSMEX NE-1500, MODIFICATION1991-12-30

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