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
1087757701
Device Listing 1087757701
Listing Summary
#
Listing key
1087757701
Premarket submission
K212623
Device
Healgen Strep A Rapid Test Strip (Throat Swab)
Applicant
Healgen Scientific,, LLC
Product code
GTY
Decision date
2022-03-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
2339
1417592
1417592
MEDLINE INDUSTRIES, LP - Northfield
1
Y
2026-01-01
Three Lakes Drive Northfield IL US 60093