KLQ
20 FDA 510(k) clearances · Product code
27 daysmedian time to decision
70 days90th percentile
20clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Amikacin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QMS AMIKACIN REAGENTS (K052815) | Seradyn, Inc. | 2005-11-01 |
| RANDOX AMIKACIN (K033884) | Randox Laboratories, Ltd. | 2004-06-09 |
| INNOFLUOR AMIKACIN ASSAY SYSTEM (K955570) | Oxis Intl., Inc. | 1996-02-09 |
| INNOFLUOR (TM) AMIKACIN REAGENT SET (K903100) | Innotron of Oregon, Inc. | 1990-08-09 |
| FPR AMIKACIN KIT (K894517) | Colony Laboratories, Inc. | 1989-09-28 |
| COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (K852317) | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| AMIKACIN ANALYTICAL TEST PACK ACA (K843211) | E.I. Dupont DE Nemours & Co., Inc. | 1984-09-12 |
| IMMPULSE AMIKACIN ASSAY REAGENTS (K841161) | Paragon Diagnostics, Inc. | 1984-05-02 |
| EMIT QST AMIKACIN ASSAY (K840193) | Syva Co. | 1984-03-23 |
| STRATUS AMIKACIN FLUOROMETRIC (K832336) | American Dade | 1983-08-31 |
| EMIT-AMD AMIKACIN ASSAY (K822657) | Dade Behring, Inc. | 1982-09-28 |
| MACRO-VUE CARD TEST, AMIKACIN (K821771) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 |
| COAT-A-COUNT AMIKACIN IRA (K820781) | Diagnostic Products Corp. | 1982-04-09 |
| AMIKACIN FLUORESCENT IMMUNOASSAY (K813541) | American Diagnostic Corp. | 1982-01-12 |
| AMES TDA TM AMIKACIN TEST (K811026) | Miles Laboratories, Inc. | 1981-04-29 |
| AMIKACIN RIA KIT (K802877) | Antibodies, Inc. | 1980-12-19 |
| CYBREX AMIKACIN (K802669) | Abbott Laboratories | 1980-11-12 |
| AMES TDA AMIKACIN (K801130) | Miles Laboratories, Inc. | 1980-05-28 |
| TOBRAM E.R.A. TM (K800517) | P-L Biochemicals, Inc. | 1980-03-20 |
| AMIKACIN (K780494) | Diagnostic Products Corp. | 1978-04-10 |
Track KLQ automatically
Every clearance here is in the API, with alerts when new ones post.