FLUID, RHEMOX W LYSING

Products, Red-cell Lysing Products

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Fluid, Rhemox W Lysing.

Pre-market Notification Details

Device IDK790029
510k NumberK790029
Device Name:FLUID, RHEMOX W LYSING
ClassificationProducts, Red-cell Lysing Products
Applicant SYSMEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGGK  
CFR Regulation Number864.8540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-03
Decision Date1979-02-26

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