Ventrex Laboratories, Inc.
Mchenry, IL, US
Ventrex Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 82 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 82
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 82FDA records hold 82 510(k) clearances for Ventrex Laboratories, Inc. between 1979 and 1992. The busiest year on record is 1979, with 13. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 13 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 11 |
| 1983 | 9 |
| 1984 | 11 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 7 |
| 1988 | 3 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 4 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | DHB | Substantially Equivalent | |
| K913833 | VENTREX ALLERGEN DISC | DHB | Substantially Equivalent | |
| K913434 | VENTREX COATED TUBE INTACT PTH | CEW | Substantially Equivalent | |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | DGC | Substantially Equivalent | |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | DHB | Substantially Equivalent | |
| K905247 | SHBG IRMA KIT | CDZ | Substantially Equivalent | |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | DHB | Substantially Equivalent | |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | JHR | Substantially Equivalent | |
| K897083 | VENTRESIGN STREP A TEST | GTZ | Substantially Equivalent | |
| K895649 | COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. | JIT | Substantially Equivalent | |
| K895648 | COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. | JIT | Substantially Equivalent | |
| K896852 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | DHB | Substantially Equivalent | |
| K896694 | VENTREZYME VAST SPECIFIC IGE ASSAY | DHB | Substantially Equivalent | |
| K891068 | VENTREX COATED TUBE T3 UPTAKE | KHQ | Substantially Equivalent | |
| K890549 | VENTREX COATED TUBE HCG | JHI | Substantially Equivalent | |
| K885157 | VENTREX COATED TUBE HIGH SENSITIVITY TSH | JLW | Substantially Equivalent | |
| K883342 | VENTREX COATED TUBE TSH | JLW | Substantially Equivalent | |
| K880678 | MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY | DHA | Substantially Equivalent | |
| K880547 | VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY | DHB | Substantially Equivalent | |
| K874258 | VENTRESCREEN, HCG URINE | JHI | Substantially Equivalent | |
| K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | GIO | Substantially Equivalent | |
| K872032 | VENTRESCREEN (TM) MONO | KTN | Substantially Equivalent | |
| K871331 | VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. | DHB | Substantially Equivalent | |
| K870009 | VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. | DHB | Substantially Equivalent | |
| K870876 | HL-1 SUPPLEMENT | KIT | Substantially Equivalent | |
| K870624 | VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY | DHB | Substantially Equivalent | |
| K862901 | VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY | DHB | Substantially Equivalent | |
| K861919 | VENTREX APO B | MSJ | Substantially Equivalent | |
| K850895 | VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY | DHB | Substantially Equivalent | |
| K851403 | VENTREZYME ALLERGEN DATA REDUCTION SYSTEM | JQW | Substantially Equivalent | |
| K844855 | VENTRESCREEN STREP A TEST | GTZ | Substantially Equivalent | |
| K843230 | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | JFH | Substantially Equivalent | |
| K842264 | VENTREZYME PHENOBARBITAL KIT IMMUNO | DLZ | Substantially Equivalent | |
| K842161 | VENTREZYME PHENYTOIN KIT IMMUNOASSAY | DIP | Substantially Equivalent | |
| K842239 | VENTRESCREEN STREP A TEST | GWC | Substantially Equivalent | |
| K841993 | HL-1, DEFINED SERUM FREE MEDIA | KIT | Substantially Equivalent | |
| K841651 | VAST VENTREX RAST ALL | DGC | Substantially Equivalent | |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | DER | Substantially Equivalent | |
| K841516 | VENTRESCREEN, MULTIPLE ALLERGEN DISCS | DHB | Substantially Equivalent | |
| K841024 | VENTREZYME T4U IMMUNOASSAY T4U | CEE | Substantially Equivalent | |
| K841081 | VENTREZYME BETA-HCG IMMUNOASSAY HCG | JHI | Substantially Equivalent | |
| K841023 | COATED TUBE HCG IMMUNOASSAY HCG | JHI | Substantially Equivalent | |
| K833423 | VENTREZYME EIA CONTROLS-IMMUNOASSAY | JJY | Substantially Equivalent | |
| K832218 | ALLERGEN CONTROL INHALENT | DGC | Substantially Equivalent | |
| K832217 | VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD | DHB | Substantially Equivalent | |
| K831554 | NEIN ALLERGEN DISC IN VAST VENTREX TEST | DHB | Substantially Equivalent | |
| K831485 | VENTRE/ZYME IGE KIT | DGC | Substantially Equivalent | |
| K830928 | VENTREX ENZYME TSH KIT | JLW | Substantially Equivalent | |
| K831091 | NEW ALLERGEN DISC -VAST VENTEX ALLERGY | DHB | Substantially Equivalent | |
| K830817 | NEW ALLERGEN DISCS FOR USE IN VAST VENT | DGC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- GTZAntisera, All Groups, Streptococcus Spp.
- GWCAntisera, All Types, Streptococcus Pneumoniae
- MSJApolipoproteins
- JQPCalculator/Data Processing Module, For Clinical Use
- JITCalibrator, Secondary
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLZEnzyme Immunoassay, Phenobarbital
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- KITMedia And Components, Synthetic Cell And Tissue Culture
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KQNRadioassay, Angiotensin Converting Enzyme
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- CGRRadioimmunoassay, Cortisol
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- DLPRadioimmunoassay, Diphenylhydantoin
- CECRadioimmunoassay, Free Thyroxine
- JHRRadioimmunoassay, Immunoglobulins (D, E)
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JQWStation, Pipetting And Diluting, For Clinical Use
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- GIOTube, Collection, Capillary Blood
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
