Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLQ — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
70 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052815 | QMS AMIKACIN REAGENTS | Seradyn, Inc. | 2005-11-01 | 28 | 0 |
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | 2004-06-09 | 177 | 0 |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | Oxis Intl., Inc. | 1996-02-09 | 65 | 0 |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Innotron of Oregon, Inc. | 1990-08-09 | 27 | 0 |
| K894517 | FPR AMIKACIN KIT | Colony Laboratories, Inc. | 1989-09-28 | 70 | 0 |
| K852317 | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR | Roche Diagnostic Systems, Inc. | 1985-06-25 | 25 | 0 |
| K843211 | AMIKACIN ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | 1984-09-12 | 28 | 0 |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 | 44 | 0 |
| K840193 | EMIT QST AMIKACIN ASSAY | Syva Co. | 1984-03-23 | 65 | 0 |
| K832336 | STRATUS AMIKACIN FLUOROMETRIC | American Dade | 1983-08-31 | 44 | 0 |
| K822657 | EMIT-AMD AMIKACIN ASSAY | Dade Behring, Inc. | 1982-09-28 | 25 | 0 |
| K821771 | MACRO-VUE CARD TEST, AMIKACIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 | 9 | 0 |
| K820781 | COAT-A-COUNT AMIKACIN IRA | Diagnostic Products Corp. | 1982-04-09 | 17 | 0 |
| K813541 | AMIKACIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 | 22 | 0 |
| K811026 | AMES TDA TM AMIKACIN TEST | Miles Laboratories, Inc. | 1981-04-29 | 13 | 0 |
| K802877 | AMIKACIN RIA KIT | Antibodies, Inc. | 1980-12-19 | 32 | 0 |
| K802669 | CYBREX AMIKACIN | Abbott Laboratories | 1980-11-12 | 16 | 0 |
| K801130 | AMES TDA AMIKACIN | Miles Laboratories, Inc. | 1980-05-28 | 16 | 0 |
| K800517 | TOBRAM E.R.A. TM | P-L Biochemicals, Inc. | 1980-03-20 | 15 | 0 |
| K780494 | AMIKACIN | Diagnostic Products Corp. | 1978-04-10 | 14 | 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