STREPTEX ZL01

Discs, Strips And Reagents, Microorganism Differentiation

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Streptex Zl01.

Pre-market Notification Details

Device IDK842828
510k NumberK842828
Device Name:STREPTEX ZL01
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-20
Decision Date1984-08-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056080501475 K842828 000
05056080501383 K842828 000
05056080501390 K842828 000
05056080501406 K842828 000
05056080501413 K842828 000
05056080501420 K842828 000
05056080501437 K842828 000
05056080501444 K842828 000
05056080501451 K842828 000
05056080501468 K842828 000
05056080501376 K842828 000

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