REES & ECKER DILUTION FLUID

Platelet Counting, Manual

E K IND., INC.

The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Rees & Ecker Dilution Fluid.

Pre-market Notification Details

Device IDK842921
510k NumberK842921
Device Name:REES & ECKER DILUTION FLUID
ClassificationPlatelet Counting, Manual
Applicant E K IND., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGLG  
CFR Regulation Number864.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-25
Decision Date1984-09-07

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