IMMUNOTECH s.r.o.
Prague Praha, Hlavni, CZ
IMMUNOTECH s.r.o. appears in FDA device records in Prague Praha, Hlavni, CZ. FDA records list 42 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to IMMUNOTECH s.r.o. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Immunotech, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 42 510(k) clearances for IMMUNOTECH s.r.o. between 1980 and 2019. The busiest year on record is 1990, with 13. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 3 |
| 1982 | 2 |
| 1984 | 2 |
| 1985 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 13 |
| 1991 | 4 |
| 1993 | 2 |
| 1995 | 6 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191350 | ACTIVE® Free Testosterone RIA | CDZ | Substantially Equivalent | |
| K954188 | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL | GKZ | Substantially Equivalent | |
| K946335 | OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES | GKZ | Substantially Equivalent | |
| K953498 | OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL | GKZ | Substantially Equivalent | |
| K952789 | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES | GKZ | Substantially Equivalent | |
| K952182 | OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES | GKZ | Substantially Equivalent | |
| K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES | GKZ | Substantially Equivalent | |
| K934012 | FT4 RADIOIMMUNOASSAY | CEC | Substantially Equivalent | |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | Substantially Equivalent | |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | CEC | Substantially Equivalent | |
| K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT | LCM | Substantially Equivalent | |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | JLW | Substantially Equivalent | |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | CEE | Substantially Equivalent | |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | DKZ | Substantially Equivalent | |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | CDP | Substantially Equivalent | |
| K904635 | MICROZYME THC ENZYME IMMUNOASSAY TEST KIT | LDJ | Substantially Equivalent | |
| K903725 | EZ-BEAD TSH ENZYME IMMUNOASSAY KIT | JLW | Substantially Equivalent | |
| K903609 | SEROTONIN ENZYME IMMUNOASSAY | CDA | Substantially Equivalent | |
| K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT | CGI | Substantially Equivalent | |
| K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT | CDX | Substantially Equivalent | |
| K902194 | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT | DJG | Substantially Equivalent | |
| K901080 | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT | DIP | Substantially Equivalent | |
| K896781 | MICRO DAU COCAINE METABOLITE TEST KIT | DIO | Substantially Equivalent | |
| K896780 | MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | JXM | Substantially Equivalent | |
| K900036 | IMMUNOTECH HDL-CHOLESTEROL TEST | LBS | Substantially Equivalent | |
| K897036 | IMMUNOTECH CHOLESTEROL TEST | CHH | Substantially Equivalent | |
| K893843 | EZ-BEAD DIGOXIN EIA KIT | KXT | Substantially Equivalent | |
| K881257 | EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT | KLS | Substantially Equivalent | |
| K872172 | IMMUBEAD THYROID UPTAKE | KHQ | Substantially Equivalent | |
| K872192 | IMMUBEAD T4 ENZYME IMMUNOASSAY KIT | KLI | Substantially Equivalent | |
| K872191 | IMMUBEAD T3 ENZYME IMMUNOASSAY KIT | CDP | Substantially Equivalent | |
| K852995 | ENDAB PHENOBARBITAL | DLZ | Substantially Equivalent | |
| K851980 | ENDAB TSH | JLW | Substantially Equivalent | |
| K840902 | ENDAB ESTRIOL UNCONJUGATED | CGI | Substantially Equivalent | |
| K834049 | ENDAB T3 | CDP | Substantially Equivalent | |
| K822684 | ENDAB THYROID UPTAKE | CEE | Substantially Equivalent | |
| K821141 | ENDAB T4 ENZYME IMMUNOASSAY KIT | CDX | Substantially Equivalent | |
| K812054 | ENDAB DIGOXIN KIT | KXT | Substantially Equivalent | |
| K810192 | ENDAB CORTISOL KIT | CGR | Substantially Equivalent | |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | KWW | Substantially Equivalent | |
| K802461 | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT | LCW | Substantially Equivalent | |
| K802066 | ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY | KLS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003385757 | 3003385757 | IMMUNOTECH s.r.o. | Radiova 1122/1, Prague Praha, Hlavni Mesto 102 00 CZ | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- GKZCounter, Differential Cell
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DLZEnzyme Immunoassay, Phenobarbital
- KLSEnzyme Immunoassay, Theophylline
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- KHQRadioassay, Triiodothyronine Uptake
- CJMRadioimmunoassay, Aldosterone
- KWWRadioimmunoassay, Cholyglycine, Bile Acids
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- LCWRadioimmunoassay, Digitoxin (125-I)
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGFRadioimmunoassay, Estrone
- CECRadioimmunoassay, Free Thyroxine
- JLSRadioimmunoassay, Progesterone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1369-2026 | 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. | Class II | Open, Classified | |
| Z-2336-2025 | 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 plasma. | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain