SYSMEX QUICKLYSER-II (QLS-200A)— 510(k) K882267

Name: FDA 510(k) clearance K882267
Creator: U.S. Food and Drug Administration
Published: 1988-07-12

Substantially Equivalent

Toa Medical Electronics USA, Inc.

FDA 510(k) clearance K882267 for SYSMEX QUICKLYSER-II (QLS-200A), Substantially Equivalent on 1988-07-12. 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: 1988-05-31
Decision date: 1988-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIF

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K883990 — KVM ISOTONIC DILUENT1988-10-12
K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT1988-07-25
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31
K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT1987-09-09

More clearances from Toa Medical Electronics USA, Inc.

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K936023 — SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER1994-05-02
K933886 — TOA MEDICAL ELECTRONICS CA-50001994-01-27
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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