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
1038174635
Device Listing 1038174635
Listing Summary
#
Listing key
1038174635
Premarket submission
K061014
Device
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Applicant
Helena Laboratories
Product code
JPA
Decision date
2006-05-10
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
3118
1618982
1618982
HELENA LABORATORIES, CORP.
1
Y
2026-01-01
1530 Lindbergh Dr BEAUMONT TX US 77707