FDA product code KLP: Amikacin Serum Assay
KLP is the FDA product code for amikacin serum assay. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under KLP, from 4 different applicants. The average 510(k) review took 56 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Amikacin Serum Assay |
| 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 KLP clearance
Top KLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 2003-10-10 |
| Em Diagnostic Systems, Inc. | 1 | 1987-10-29 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1979-05-23 |
| Monitor Science Corp. | 1 | 1978-08-14 |
Most recent KLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032279 | Roche Diagnostics Corp. | ONLINE TDM AMIKA | 2003-10-10 | 78 |
| K873426 | Em Diagnostic Systems, Inc. | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 | 1987-10-29 | 65 |
| K790899 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC | 1979-05-23 | 14 |
| K780949 | Monitor Science Corp. | BIO-MONITOR AMIKACIN | 1978-08-14 | 66 |
Recalls for KLP devices
openFDA lists no recalls for product code KLP.
Frequently asked questions
What is FDA product code KLP?
KLP is the FDA product code for amikacin serum assay. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel.
What device class is KLP?
Class II, regulation 21 CFR 862.3035. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLP?
Across 4 cleared submissions the average was 56 days from receipt to decision (median 66).
Which companies have the most KLP clearances?
Roche Diagnostics Corp. (1); Em Diagnostic Systems, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Monitor Science Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLP
- Run a recall and safety report across every KLP manufacturer
- Watch product code KLP 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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