ULTRAZYME HBD

Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

HARLECO

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

Pre-market Notification Details

Device IDK760023
510k NumberK760023
Device Name:ULTRAZYME HBD
ClassificationAcid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Applicant HARLECO 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJMK  
CFR Regulation Number862.1380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-14
Decision Date1976-08-26

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