ROCHE LACTATE ANALYZER 640

Acid, Lactic, Enzymatic Method

ROCHE MEDICAL ELECTRONICS, INC.

The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Roche Lactate Analyzer 640.

Pre-market Notification Details

Device IDK790421
510k NumberK790421
Device Name:ROCHE LACTATE ANALYZER 640
ClassificationAcid, Lactic, Enzymatic Method
Applicant ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHP  
CFR Regulation Number862.1450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-28
Decision Date1979-05-15

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