SALADAX BIOMEDICAL, INC.

FDA Device Registration & Listing · BETHLEHEM, PA, US · Registration 3005567065

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005567065
FEI Number
3005567065
Entity Name
SALADAX BIOMEDICAL, INC.
City/State/Country
BETHLEHEM, PA, US
Establishment Address
116 RESEARCH DR., BETHLEHEM, PA 18015, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
SALADAX BIOMEDICAL, INC. (Owner Number: 9097239)
Owner / Operator Contact Address
116 RESEARCH DR., --, Bethlehem, PA 18015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MyCare Psychiatry Clozapine Assay Kit MyDocetaxel Assay Kit MyPaclitaxel Assay Kit MyImatinib Calibrator Kit MyCare Psychiatry Calibrator Kit 2 MyCare Psychiatry Calibrator Kit 1 My5-FU Calibrator Kit MyDocetaxel Calibrator Kit MyPaclitaxel Calibrator Kit MyCare Psychiatry Control Kit 2 My5-FU Sample Stabilizer My5-FU Assay MyImatinib Control Kit MyCare Psychiatry Control Kit 2 MyCare Psychiatry Control Kit 1 My5-FU Control Kit MyPaclitaxel Control Kit MyDocetaxel Control Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKT Clozapine Test System Clinical Chemistry Class 2 862.3245 2020-04-17
PRF Docetaxel / Paclitaxel Assay Unknown Class N N/A 2018-10-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2011-08-19
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2020-04-17
OXR 5-Fluorouracil Assay Unknown Class N N/A 2011-08-25
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2011-08-19

Official Correspondent

Salvatore Salamone, PhD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SALADAX BIOMEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K780731 Vitek Systems, Inc. LIDOCAINE CALIBRATOR KIT 1979-01-17
K833380 E.I. Dupont DE Nemours & Co., Inc. LIDOAINE CALIBRATOR 1983-12-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005567065. Last updated year: 2026. Please use registration number 3005567065 when referencing this establishment in official correspondence.
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