Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Diagnostic Technology — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
100 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Intl. Diagnostic Technology | 1985-04-30 | 75 | 0 |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | Intl. Diagnostic Technology | 1984-10-05 | 24 | 0 |
| K843621 | FIAX 420 DILUTOR | Intl. Diagnostic Technology | 1984-09-28 | 14 | 0 |
| K843356 | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | 1984-09-17 | 21 | 0 |
| K842749 | FIAX TOTAL IGE TEST KIT | Intl. Diagnostic Technology | 1984-08-28 | 46 | 0 |
| K842071 | FIAX TRANSFERRIN TEST KIT | Intl. Diagnostic Technology | 1984-07-11 | 49 | 0 |
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Intl. Diagnostic Technology | 1984-06-07 | 80 | 0 |
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | Intl. Diagnostic Technology | 1984-05-11 | 74 | 0 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | 1984-01-20 | 51 | 0 |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | 1984-01-04 | 48 | 0 |
| K832821 | FIAX IGG TEST | Intl. Diagnostic Technology | 1983-10-14 | 56 | 0 |
| K832383 | IDT ANA STIQ ASSAY | Intl. Diagnostic Technology | 1983-08-31 | 43 | 0 |
| K832054 | FIAX CRP TEST KIT | Intl. Diagnostic Technology | 1983-08-26 | 60 | 0 |
| K831607 | FIAX IGA TEST KIT | Intl. Diagnostic Technology | 1983-06-22 | 35 | 0 |
| K831608 | FIAX IGM TEST KIT | Intl. Diagnostic Technology | 1983-06-22 | 35 | 0 |
| K831609 | FIAX IGG TEST KIT | Intl. Diagnostic Technology | 1983-06-17 | 30 | 0 |
| K830669 | FIAX COMPLEMENT C4 TEST KIT | Intl. Diagnostic Technology | 1983-04-08 | 35 | 0 |
| K830668 | FIAX COMPLEMENT C3 TEST KIT | Intl. Diagnostic Technology | 1983-04-05 | 32 | 0 |
| K812968 | FIAX RHEUMATOID FACTOR TEST KIT | Intl. Diagnostic Technology | 1981-11-06 | 15 | 0 |
| K801642 | FIAX TEST KIT FOR THEOPHYLLINE QUANT. | Intl. Diagnostic Technology | 1980-08-27 | 41 | 0 |
| K801308 | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | Intl. Diagnostic Technology | 1980-06-20 | 17 | 0 |
| K792559 | FIAX TEST KIT FOR HERPES SIMPLEX VIRUS | Intl. Diagnostic Technology | 1980-03-03 | 83 | 0 |
| K800032 | FIAX TEST KIT FOR GENTAMICIN QUAN. | Intl. Diagnostic Technology | 1980-01-23 | 16 | 0 |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | Intl. Diagnostic Technology | 1980-01-23 | 77 | 0 |
| K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS | Intl. Diagnostic Technology | 1979-11-16 | 46 | 0 |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | Intl. Diagnostic Technology | 1979-06-13 | 100 | 0 |
| K761224 | ULTRA LOW LEVEL IMMUNOGLOBULIN G | Intl. Diagnostic Technology | 1977-04-07 | 120 | 0 |
| K761225 | LOW LEVEL HUMAN ALBUMIN TEST KITS | Intl. Diagnostic Technology | 1977-04-07 | 120 | 0 |
| K760206 | TEST, DETECTION, ANTINUCLEAR ANTIBODIES | Intl. Diagnostic Technology | 1976-08-03 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda