VARIOUS REAGENTS FOR BLOOD CELL ANALYZER

Diluent, Blood Cell

LABORATORY PRODUCTS, INC.

The following data is part of a premarket notification filed by Laboratory Products, Inc. with the FDA for Various Reagents For Blood Cell Analyzer.

Pre-market Notification Details

Device IDK800180
510k NumberK800180
Device Name:VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
ClassificationDiluent, Blood Cell
Applicant LABORATORY PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGIF  
CFR Regulation Number864.8200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-29
Decision Date1980-03-19

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