CHOLESTEROL AQUEOUS STANDARD

Calibrator, Primary

PREVENTIVE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Cholesterol Aqueous Standard.

Pre-market Notification Details

Device IDK840217
510k NumberK840217
Device Name:CHOLESTEROL AQUEOUS STANDARD
ClassificationCalibrator, Primary
Applicant PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-19
Decision Date1984-03-23

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