Data / Medical devices / United States / Sure-Tech Diagnostic Associates, Inc.
Sure-Tech Diagnostic Associates, Inc.: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Sure-Tech Diagnostic Associates, Inc. is registered with the FDA (registration 1938095) in Saint Louis, MO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 17, 1989. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1938095
- Address
- 12115 Tesson Ferry Professional Ctr, Saint Louis, MO, United States, 63128
- Owner or operator
- SURE-TECH DIAGNOSTIC ASSOCIATES, INC. (1938095)
- Roles
- Manufacturer
- First device listed
- January 7, 2008
- Registered through
- 2026
- Brand names listed
- FETAL HEMOGLOBIN KIT, Fetal Hemoglobin Control, KLEIHAUER-BETKE KIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mixture, Hematology Quality Control | JPK | 2 | Manufacturer | accessdata.fda.gov |
| Stain, Fetal Hemoglobin | GHQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 17, 1989 | K892241 | FETAL HEMOGLOBIN | GHQ | Substantially Equivalent | Sure-Tech Diagnostic Associates, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 17, 1989. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.