Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1466398560
Device Listing 1466398560
Listing Summary
#
Listing key
1466398560
Premarket submission
K011843
Device
GENZYME DIRECT-AMYLASE TEST REAGENT
Applicant
Genzyme Corp.
Product code
JFJ
Decision date
2001-08-10
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
126394
8020316
3002806809
Sekisui Diagnostics P.E.I. Inc.
1
N
2026-01-01
70 Watts Avenue CHARLOTTETOWN Prince Edward Island CA C1E 2B9