FDA.reportPublic FDA data

Device Listing 1417738613

Listing Summary#

Listing key
1417738613
Premarket submission
K964721
Device
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
Product code
KLI
Decision date
1996-12-18