FDA.reportPublic FDA data

Device Listing 1183794043

Listing Summary#

Listing key
1183794043
Premarket submission
K964720
Device
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
Product code
CGJ
Decision date
1997-02-04