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
1607911887
Device Listing 1607911887
Listing Summary
#
Listing key
1607911887
Premarket submission
K974108
Device
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
Applicant
Quidel Corp.
Product code
JJX
Decision date
1997-11-26
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
4995
2024674
2024674
QUIDEL CORP.
1
N
2026-01-01
10165 MCKELLAR CT. SAN DIEGO CA US 92121
333654
3033751096
3033751096
Ortho-Clinical Diagnostics, Inc.
1
N
2026-01-01
9975 Summers Ridge Rd San Diego CA US 92121