Saladax Biomedical Inc

FDA Filings

This page includes the latest FDA filings for Saladax Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Saladax Biomedical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005567065
FEI Number3005567065
NameSALADAX BIOMEDICAL, INC.
Owner & OperatorSALADAX BIOMEDICAL, INC.
Contact Address116 RESEARCH DR. --
Bethlehem PA 18015 US
Official Correspondent
  • Sue Werner
  • x-585-6420384-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address116 RESEARCH DR.
BETHLEHEM, PA 18015 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry MCP2-CON-US2020-05-25
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry MCP2-CAL-US2020-05-25
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry CLZ-RGT2020-05-25
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Clozapine Assay Kit2020-04-17
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Control Kit 22020-04-17
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Calibrator Kit 22020-04-17
Saladax Biomedical Inc
MyCare Psychiatry Clozapine Assay Kit2020-04-16
SALADAX BIOMEDICAL, INC.
MyPaclitaxel Assay Kit2018-10-19
SALADAX BIOMEDICAL, INC.
MyDocetaxel Assay Kit2018-10-19
SALADAX BIOMEDICAL, INC.
My5-FU Sample Stabilizer2011-08-25
SALADAX BIOMEDICAL, INC.
My5-FU Assay2011-08-25
SALADAX BIOMEDICAL, INC.
MyPaclitaxel Control Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyImatinib Control Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyDocetaxel Control Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Control Kit 22011-08-19
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Control Kit 12011-08-19
SALADAX BIOMEDICAL, INC.
My5-FU Control Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyPaclitaxel Calibrator Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyImatinib Calibrator Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyDocetaxel Calibrator Kit2011-08-19
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Calibrator Kit 22011-08-19
SALADAX BIOMEDICAL, INC.
MyCare Psychiatry Calibrator Kit 12011-08-19
SALADAX BIOMEDICAL, INC.
My5-FU Calibrator Kit2011-08-19

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