ULTRAZYME PLUS GT

Colorimetric Method, Gamma-glutamyl Transpeptidase

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Ultrazyme Plus Gt.

Pre-market Notification Details

Device IDK780099
510k NumberK780099
Device Name:ULTRAZYME PLUS GT
ClassificationColorimetric Method, Gamma-glutamyl Transpeptidase
Applicant HARLECO 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJPZ  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-20
Decision Date1978-03-09

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