Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hitachi Chemical Diagnostics, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
444 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle | Hitachi Chemical Diagnostics, Inc. | 2021-10-18 | 662 | 0 |
| K182793 | AP3600 Automated Instrument | Hitachi Chemical Diagnostics, Inc. | 2019-03-19 | 169 | 0 |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014-03-11 | 40 | 0 |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CR | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 | 82 | 0 |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD A | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 | 149 | 0 |
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITA | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | 435 | 0 |
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBU | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | 53 | 0 |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | 38 | 0 |
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM ( | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 | 34 | 0 |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | Hitachi Chemical Diagnostics, Inc. | 2013-03-22 | 59 | 0 |
| K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT | Hitachi Chemical Diagnostics, Inc. | 2012-12-20 | 444 | 0 |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 | 238 | 0 |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE ( | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 | 94 | 0 |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLE | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 | 175 | 0 |
| K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | Hitachi Chemical Diagnostics, Inc. | 2006-01-23 | 216 | 1 |
| K030590 | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) | Hitachi Chemical Diagnostics, Inc. | 2003-03-21 | 24 | 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