Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DJB — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
191 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | 1983-09-29 | 44 | 0 |
| K831210 | GENTAMICIN TEST PACK-ACA | E.I. Dupont DE Nemours & Co., Inc. | 1983-05-25 | 41 | 0 |
| K821669 | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | 1982-12-15 | 191 | 0 |
| K812394 | MRI GENTAMICIN RIA KIT | Microanalytic Research, Inc. | 1981-09-08 | 19 | 0 |
| K811844 | COAT-A-COUNT GENTAMICIN RIA KIT | Diagnostic Products Corp. | 1981-07-10 | 9 | 0 |
| K800537 | GAMMA STICK GENTAMICIN RIA KIT | Alpha Gamma Laboratory | 1980-04-24 | 45 | 0 |
| K791770 | QUANTIMUNE GENTAMICIN RIA GENTAMICIN | Bio-Rad | 1979-10-17 | 40 | 0 |
| K791547 | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY | Bio-Rad | 1979-10-12 | 63 | 0 |
| K782049 | BIOASSAY SYSTEM, MS-2 SERUM | Abbott Laboratories | 1979-08-28 | 263 | 0 |
| K790584 | AMES TDA/GENTGMICIN | Miles Laboratories, Inc. | 1979-06-15 | 80 | 0 |
| K790829 | EMIT GENTAMICIN ASSAY | Syva Co. | 1979-05-15 | 15 | 0 |
| K782126 | RIA KIT, SISOMICIN | Diagnostic Products Corp. | 1979-02-15 | 50 | 0 |
| K781674 | MACRO-VUE TEST, GENTAMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-15 | 43 | 0 |
| K780516 | GENTAMICIN RIA KIT | Antibodies, Inc. | 1978-04-28 | 29 | 0 |
| K772116 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | 1978-04-28 | 172 | 0 |
| K780323 | QUANTITOPE 125-I GENTAMICIN RIA KIT | Kallestad Laboratories, Inc. | 1978-03-17 | 18 | 0 |
| K772425 | RIANEN GENTAMICIN RIA KIT | New England Nuclear | 1978-01-05 | 7 | 0 |
| K761157 | AMINOGLYCOSIDE (125I) RIA KIT | Diagnostic Products Corp. | 1977-03-01 | 92 | 0 |
| K760068 | KIT, RIA, GENTAMICIN SULF. | New England Nuclear | 1976-07-20 | 34 | 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