Intl. Diagnostic Technology
Mchenry, IL, US
Intl. Diagnostic Technology appears in FDA device records in Mchenry, IL. FDA records list 29 510(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
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Intl. Diagnostic Technology between 1976 and 1985. The busiest year on record is 1984, with 9. The most recent is 1985, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1979 | 2 |
| 1980 | 5 |
| 1981 | 1 |
| 1983 | 8 |
| 1984 | 9 |
| 1985 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | GLZ | Substantially Equivalent | |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | DAB | Substantially Equivalent | |
| K843621 | FIAX 420 DILUTOR | JQW | Substantially Equivalent | |
| K843356 | FIAX 100 FLUOROMETER | JZT | Substantially Equivalent | |
| K842749 | FIAX TOTAL IGE TEST KIT | DGP | Substantially Equivalent | |
| K842071 | FIAX TRANSFERRIN TEST KIT | DDI | Substantially Equivalent | |
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | GOL | Substantially Equivalent | |
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | DEI | Substantially Equivalent | |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | KTL | Substantially Equivalent | |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | KTL | Substantially Equivalent | |
| K832821 | FIAX IGG TEST | DFI | Substantially Equivalent | |
| K832383 | IDT ANA STIQ ASSAY | DHN | Substantially Equivalent | |
| K832054 | FIAX CRP TEST KIT | DCK | Substantially Equivalent | |
| K831608 | FIAX IGM TEST KIT | DFT | Substantially Equivalent | |
| K831607 | FIAX IGA TEST KIT | CZN | Substantially Equivalent | |
| K831609 | FIAX IGG TEST KIT | DGK | Substantially Equivalent | |
| K830669 | FIAX COMPLEMENT C4 TEST KIT | DBI | Substantially Equivalent | |
| K830668 | FIAX COMPLEMENT C3 TEST KIT | CZW | Substantially Equivalent | |
| K812968 | FIAX RHEUMATOID FACTOR TEST KIT | DHR | Substantially Equivalent | |
| K801642 | FIAX TEST KIT FOR THEOPHYLLINE QUANT. | KLS | Substantially Equivalent | |
| K801308 | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | LCR | Substantially Equivalent | |
| K792559 | FIAX TEST KIT FOR HERPES SIMPLEX VIRUS | GQL | Substantially Equivalent | |
| K800032 | FIAX TEST KIT FOR GENTAMICIN QUAN. | LCQ | Substantially Equivalent | |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | GOL | Substantially Equivalent | |
| K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS | GQH | Substantially Equivalent | |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | GLZ | Substantially Equivalent | |
| K761225 | LOW LEVEL HUMAN ALBUMIN TEST KITS | DCF | Substantially Equivalent | |
| K761224 | ULTRA LOW LEVEL IMMUNOGLOBULIN G | DEW | Substantially Equivalent | |
| K760206 | TEST, DETECTION, ANTINUCLEAR ANTIBODIES | DHN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GOLAntigen, Ha (Including Ha Control), Rubella
- GLZAntigens, If, Toxoplasma Gondii
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- KLSEnzyme Immunoassay, Theophylline
- LCQFluorescent Immunoassay Gentamicin
- LCRFluorescent Immunoassay, Tobramycin
- JZTFluorometer
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- DGPIge, Fitc, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DGKIgg, Fitc, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- JQWStation, Pipetting And Diluting, For Clinical Use
- DHRSystem, Test, Rheumatoid Factor
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control
- DDITransferrin, Fitc, Antigen, Antiserum, Control
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