FDA.reportPublic FDA data

SALADAX BIOMEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055670653005567065SALADAX BIOMEDICAL, INC.1N2026-01-01116 RESEARCH DR. BETHLEHEM PA US 18015

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00894354002212MyCare Psychiatry - Calibrator Kit 2+1 (610) 419-6731Techsupport@saladax.com
00894354002229MyCare Psychiatry - Control Kit 2+1 (610) 419-6731Techsupport@saladax.com
00894354002236MyCare Psychiatry - Clozapine Assay Kit+1 (610) 419-6731Techsupport@saladax.com
00894354002304MyCare Psychiatry - Calibrator Kit 2+1 (610) 419-6731Techsupport@saladax.com
00894354002311MyCare Psychiatry - Control Kit 2+1 (610) 419-6731Techsupport@saladax.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
678321862168198DEN190028MyCare Psychiatry Clozapine Assay KitQKT2020-04-16
678321422253151
678321466990016
678321524020010
678321710158589
678321908659775
678322036592684

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKT12020-04-16

GUDID#