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
1412821085
Device Listing 1412821085
Listing Summary
#
Listing key
1412821085
Premarket submission
K962926
Device
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
Applicant
American Laboratory Products Co., Ltd.
Product code
MID
Decision date
1996-10-10
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
16128
3003232042
3003232042
ORGENTEC DIAGNOSTIKA GMBH
1
N
2026-01-01
CARL-ZEISS-STRASSE 49-51 MAINZ Rhineland-Palatinate DE 55129