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
1690299381
Device Listing 1690299381
Listing Summary
#
Listing key
1690299381
Premarket submission
K993317
Device
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
Applicant
ACON Laboratories, Inc.
Product code
JHI
Decision date
1999-12-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
13830
2027969
1000125596
Alere San Diego, Inc.
1
Y
2020-04-25
9975 SUMMERS RIDGE RD SAN DIEGO CA US 92121
346957
2027969
1000125596
Alere San Diego, Inc.
1
N
2026-01-01
9942 Mesa Rim Road 9942 Mesa Rim Road San Diego CA US 92121
13827
3005641941
3005641941
ABON BIOPHARM (HANGZHOU) CO., LTD.
1
N
2020-04-25
#198 12th Street East, HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA HANGZHOU, ZHEJIANG Zhejiang CN 310018
346970
3005641941
3005641941
Irene Yasuda
1
N
2026-01-01
9940 Mesa Rim Rd San Diego CA US 92121