Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCQ — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
119 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972609 | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM | Bio-Rad | 1997-08-06 | 26 | 0 |
| K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Oxis Intl., Inc. | 1996-02-09 | 65 | 0 |
| K945523 | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMIC | Roche Diagnostic Systems, Inc. | 1995-03-09 | 119 | 0 |
| K943550 | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1994-11-17 | 119 | 0 |
| K905721 | OPUS GENTAMICIN | Pb Diagnostic Systems, Inc. | 1991-02-21 | 62 | 0 |
| K904226 | 'TDXFLX ANALYZER | Abbott Laboratories | 1990-10-29 | 46 | 0 |
| K894523 | FPR GENTAMICIN KIT | Colony Laboratories, Inc. | 1989-09-28 | 70 | 0 |
| K852158 | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA | Bioprobe Intl., Inc. | 1985-06-25 | 39 | 0 |
| K852013 | GENTAMICIN KIT(FPIA) | Windsor Laboratories, Inc. | 1985-06-10 | 32 | 0 |
| K843827 | COBAS REAGENTS FOR GENTAMICIN & CALIBRAT | Roche Diagnostic Systems, Inc. | 1985-02-01 | 126 | 0 |
| K841865 | INNOFLOUR GENTAMICIN | Innotron Diagnostics | 1984-05-31 | 27 | 0 |
| K841162 | IMMPULSE GENTAMICIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 | 44 | 0 |
| K820285 | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY | Syva Co. | 1982-02-18 | 16 | 0 |
| K813539 | GENTAMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 | 10 | 0 |
| K810942 | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | 1981-04-17 | 10 | 0 |
| K801867 | DISPOSABLE MEDICATION NEBULIZER | Hospitax | 1980-08-20 | 15 | 1 |
| K801084 | CYBREX GENTAMICIN | Abbott Laboratories | 1980-05-23 | 16 | 2 |
| K800032 | FIAX TEST KIT FOR GENTAMICIN QUAN. | Intl. Diagnostic Technology | 1980-01-23 | 16 | 0 |
| K782025 | GENTAMICIN FLUROIMMUNASSAY KIT | Technia Diagnostics , Ltd. | 1979-01-26 | 52 | 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