FLUID, RHEMOX-HB LYSING— 510(k) K790030

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K790030 for FLUID, RHEMOX-HB LYSING, Substantially Equivalent on 1979-02-08. Applicant: Sysmex Corp.. Device class: 2.

Clearance details

Applicant: Sysmex Corp.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1979-01-03
Decision date: 1979-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sysmex Corp.

K012372 — SYSMEX UF-502001-09-28
K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER1999-11-09
K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-35001998-11-03
K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER1998-08-14
K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER1997-08-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.