FDA product code KLQ: Radioimmunoassay, Amikacin
KLQ is the FDA product code for radioimmunoassay, amikacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel. FDA has cleared 20 510(k) submissions under KLQ, from 18 different applicants. The average 510(k) review took 38 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Amikacin |
| Device class | Class II |
| Regulation | 21 CFR 862.3035 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KLQ clearance
Top KLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1982-04-09 |
| Miles Laboratories, Inc. | 2 | 1981-04-29 |
| Seradyn, Inc. | 1 | 2005-11-01 |
| Randox Laboratories, Ltd. | 1 | 2004-06-09 |
| Oxis Intl., Inc. | 1 | 1996-02-09 |
13 more applicants have KLQ clearances. See the full list in Caduvo.
Most recent KLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052815 | Seradyn, Inc. | QMS AMIKACIN REAGENTS | 2005-11-01 | 28 |
| K033884 | Randox Laboratories, Ltd. | RANDOX AMIKACIN | 2004-06-09 | 177 |
| K955570 | Oxis Intl., Inc. | INNOFLUOR AMIKACIN ASSAY SYSTEM | 1996-02-09 | 65 |
| K903100 | Innotron of Oregon, Inc. | INNOFLUOR (TM) AMIKACIN REAGENT SET | 1990-08-09 | 27 |
| K894517 | Colony Laboratories, Inc. | FPR AMIKACIN KIT | 1989-09-28 | 70 |
Recalls for KLQ devices
openFDA lists no recalls for product code KLQ.
Frequently asked questions
What is FDA product code KLQ?
KLQ is the FDA product code for radioimmunoassay, amikacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel.
What device class is KLQ?
Class II, regulation 21 CFR 862.3035. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLQ?
Across 20 cleared submissions the average was 38 days from receipt to decision (median 26).
Which companies have the most KLQ clearances?
Diagnostic Products Corp. (2); Miles Laboratories, Inc. (2); Seradyn, Inc. (1); Randox Laboratories, Ltd. (1); Oxis Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLQ
- Run a recall and safety report across every KLQ manufacturer
- Watch product code KLQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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