HEMATOLOGY WRIGHT'S STAIN PACK

Wright's Stain

J.S. MEDICAL ASSOC.

The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Hematology Wright's Stain Pack.

Pre-market Notification Details

Device IDK833678
510k NumberK833678
Device Name:HEMATOLOGY WRIGHT'S STAIN PACK
ClassificationWright's Stain
Applicant J.S. MEDICAL ASSOC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIAF  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-18
Decision Date1983-11-25

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