FDA.reportPublic FDA data

Device Listing 1329574504

Listing Summary#

Listing key
1329574504
Premarket submission
K063164
Device
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
LDJ
Decision date
2006-12-28