Data / Medical devices / Czechia / IMMUNOTECH s.r.o.
IMMUNOTECH s.r.o.: FDA-registered device maker in Prague Praha, Hlavni Mesto, Czechia, 7 510(k) clearances
IMMUNOTECH s.r.o. is registered with the FDA (registration 3003385757) in Prague Praha, Hlavni Mesto, Czechia. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 20, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003385757
- Address
- Radiova 1122/1, Prague Praha, Hlavni Mesto, Czechia, 102 00
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Manufacturer
- First device listed
- December 7, 2017
- Registered through
- 2026
- Brand names listed
- ACTIVE® Aldosterone RIA, ACTIVE® Free Testosterone RIA, DHEA RIA, DHEA-S-7 RIA, Estrone RIA, Estrone Sulfate RIA, Ultra-Sensitive Estradiol Radioimmunoassay (RIA)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry | JKL | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Aldosterone | CJM | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estrone | CGF | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | 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 |
|---|---|---|---|---|---|---|
| December 20, 2019 | K191350 | ACTIVE® Free Testosterone RIA | CDZ | Substantially Equivalent | Immunotech S.R.O. | accessdata.fda.gov |
| May 16, 1997 | K970915 | DSL ESTRONE-SULFATE RIA | CGF | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
| September 10, 1996 | K962895 | DSL DHEA-S-7 | JKC | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
| October 2, 1995 | K953605 | ULTRA-SENSITIVE ESTRADIOL | CHP | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
| February 13, 1995 | K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | CJM | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
| June 16, 1994 | K935013 | DSL ESTRONE (DSL 8700) | CGF | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
| May 26, 1992 | K921534 | DSL DHEA (DSL 8900) | JKL | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2025 | 98219 | Class II | Ongoing | Estrone RIA, REF: DSL8700 | The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur. | accessdata.fda.gov |
| June 12, 2025 | 97090 | Class II | Ongoing | Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plas | Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur. | accessdata.fda.gov |
Compare with other makers
- All makers of Radioimmunoassay, Estrone
- All makers of Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
- All makers of Radioimmunoassay, Estradiol
- All makers of Radioimmunoassay, Testosterones And Dihydrotestosterone
- All makers of Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- All makers of Radioimmunoassay, Aldosterone
Updated February 13, 2026. 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.