AUTOLYZER 800

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 Autolyzer 800.

Pre-market Notification Details

Device IDK841852
510k NumberK841852
Device Name:AUTOLYZER 800
ClassificationCounter, Differential Cell
Applicant GEOMETRIC DATA, DIV. SMITHKLINE CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-03
Decision Date1984-09-05

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