PARA-PAK CLEAN VIAL

Container, Specimen, Sterile

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Para-pak Clean Vial.

Pre-market Notification Details

Device IDK792710
510k NumberK792710
Device Name:PARA-PAK CLEAN VIAL
ClassificationContainer, Specimen, Sterile
Applicant MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMH  
CFR Regulation Number864.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-27
Decision Date1980-01-28

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