STAIN, HEMASTAIN RETIC

Stain, Reticulocyte

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 Stain, Hemastain Retic.

Pre-market Notification Details

Device IDK790042
510k NumberK790042
Device Name:STAIN, HEMASTAIN RETIC
ClassificationStain, Reticulocyte
Applicant GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGJH  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-05
Decision Date1979-02-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.