FDA.reportPublic FDA data

Device Listing 1836532856

Listing Summary#

Listing key
1836532856
Premarket submission
K965142
Device
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
Product code
CEC
Decision date
1997-03-18