HEMATRAK RBC MORPHOLOGY

Counter, Differential Cell

GEOMETRIC DATA, DIV. SMITHKLINE CORP.

The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hematrak Rbc Morphology.

Pre-market Notification Details

Device IDK761207
510k NumberK761207
Device Name:HEMATRAK RBC MORPHOLOGY
ClassificationCounter, Differential Cell
Applicant GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-12-07
Decision Date1977-10-18

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