Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GGT — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
215 daysmedian FDA review time
391 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240182 | Access EPO | Beckman Coulter, Inc. | 2024-04-22 | 90 | 0 |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019-08-02 | 269 | 2 |
| K052223 | ACCESS EPO ASSAY | Beckman Coulter, Inc. | 2006-10-06 | 417 | 1 |
| K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | Sangui Biotech, Inc. | 2000-06-07 | 293 | 0 |
| K983203 | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | Diagnostic Products Corp. | 1999-07-12 | 301 | 0 |
| K980737 | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | Nichols Institute Diagnostics | 1999-03-23 | 391 | 0 |
| K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT | Nichols Institute | 1996-05-29 | 362 | 0 |
| K954898 | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | Genzyme Corp. | 1996-02-05 | 138 | 0 |
| K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT AS | R&D Systems, Inc. | 1994-07-19 | 215 | 0 |
| K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | R&D Systems, Inc. | 1994-04-21 | 378 | 1 |
| K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT | Nichols Institute | 1994-03-11 | 282 | 0 |
| K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | R&D Systems, Inc. | 1993-07-20 | 105 | 0 |
| K926390 | PREDICTA ERYTHROPOIETIN KIT | Genzyme Corp. | 1993-06-25 | 185 | 0 |
| K910481 | EPO-RIA | Ramco Laboratories, Inc. | 1991-11-29 | 296 | 0 |
| K903492 | DSL ERYTHROPOIETIN (DSL # 1100) | Diagnostic Systems Laboratories, Inc. | 1990-10-26 | 84 | 0 |
| K902639 | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) | Incstar Corp. | 1990-08-22 | 69 | 0 |
| K893393 | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) | Incstar Corp. | 1989-11-21 | 204 | 0 |
| K894943 | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 | Amgen, Inc. | 1989-10-10 | 68 | 0 |
| K882686 | ERYTHROPOIETIN ENZYME IMMUNOASSAY | Amgen, Inc. | 1988-12-20 | 173 | 0 |
| K833957 | ERYTHROPOIETIN EIA | Jcl Clinical Research Corp. | 1984-03-23 | 128 | 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