UCG-BETA SLIDE MONOCLONAL

Agglutination Method, Human Chorionic Gonadotropin

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Ucg-beta Slide Monoclonal.

Pre-market Notification Details

Device IDK831775
510k NumberK831775
Device Name:UCG-BETA SLIDE MONOCLONAL
ClassificationAgglutination Method, Human Chorionic Gonadotropin
Applicant ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHJ  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-02
Decision Date1983-08-11

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