Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reference Diagnostics, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
295 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 | Reference Diagnostics, Inc. | 2006-03-13 | 108 | 0 |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | 2006-03-13 | 117 | 0 |
| K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALI | Reference Diagnostics, Inc. | 2005-11-09 | 93 | 0 |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | Reference Diagnostics, Inc. | 2003-09-30 | 267 | 0 |
| K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET | Reference Diagnostics, Inc. | 2003-04-11 | 31 | 0 |
| K021609 | RDI HS CRP KIT | Reference Diagnostics, Inc. | 2002-06-27 | 42 | 0 |
| K021607 | RDI HS CRP CALIBRATOR SET | Reference Diagnostics, Inc. | 2002-06-27 | 42 | 0 |
| K000783 | DIRECT TIBC CALIBRATOR | Reference Diagnostics, Inc. | 2000-05-04 | 55 | 0 |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | 2000-05-02 | 53 | 0 |
| K990216 | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | 1999-02-16 | 25 | 0 |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1999-01-28 | 72 | 0 |
| K973988 | RDI HOMOGENEOUS HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1997-12-22 | 62 | 0 |
| K964063 | RDI LDL PRECIPITATION REAGENT | Reference Diagnostics, Inc. | 1996-11-20 | 41 | 0 |
| K964064 | RDI LIPIDIRECT MAGNETIC LDL REAGENT | Reference Diagnostics, Inc. | 1996-11-20 | 41 | 0 |
| K944975 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1995-08-02 | 295 | 0 |
| K911906 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1991-07-18 | 79 | 0 |
| K893740 | LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES | Reference Diagnostics, Inc. | 1990-03-19 | 306 | 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