SURE-TECH DIAGNOSTIC ASSOCIATES, INC.

FDA Device Registration & Listing · Saint Louis, MO, US · Registration 1938095

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
1938095
FEI Number
1938095
Entity Name
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
City/State/Country
Saint Louis, MO, US
Establishment Address
12115 Tesson Ferry Professional Ctr, Saint Louis, MO 63128, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SURE-TECH DIAGNOSTIC ASSOCIATES, INC. (Owner Number: 1938095)
Owner / Operator Contact Address
12115 Tesson Ferry Professional Center, --, Saint Louis, MO 63128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KLEIHAUER-BETKE KIT FETAL HEMOGLOBIN KIT Fetal Hemoglobin Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GHQ Stain, Fetal Hemoglobin Hematology Class 2 864.7455 2008-01-07
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2024-01-09

Official Correspondent

Thomas Buck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURE-TECH DIAGNOSTIC ASSOCIATES, 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
K781077 Dade, Baxter Travenol Diagnostics, Inc. CONTROL, HEMATOLOGY, CH-60 1978-07-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1938095. Last updated year: 2026. Please use registration number 1938095 when referencing this establishment in official correspondence.
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