FDA product code KLR: Enzyme Immunoassay, Lidocaine
KLR is the FDA product code for enzyme immunoassay, lidocaine. It is a Class II device, regulated under 21 CFR 862.3555 and reviewed by the Clinical Toxicology panel. FDA has cleared 17 510(k) submissions under KLR, from 11 different applicants. The average 510(k) review took 59 days (median 55). FDA has posted 1 recall for KLR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Lidocaine |
| Device class | Class II |
| Regulation | 21 CFR 862.3555 |
| 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 KLR clearance
Top KLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 6 | 1983-12-08 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1983-12-27 |
| Thermo Fisher Scientific, Inc. | 1 | 2009-05-29 |
| Dade Behring, Inc. | 1 | 2004-02-20 |
| Roche Diagnostics Corp. | 1 | 2004-01-12 |
6 more applicants have KLR clearances. See the full list in Caduvo.
Most recent KLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090282 | Thermo Fisher Scientific, Inc. | QMS LIDOCAINE | 2009-05-29 | 113 |
| K033809 | Dade Behring, Inc. | DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D | 2004-02-20 | 74 |
| K032334 | Roche Diagnostics Corp. | ROCHE ONLINE TDM LIDOCAINE | 2004-01-12 | 167 |
| K973102 | Diagnostic Reagents, Inc. | LIDOCAINE EIA ASSAY | 1997-09-12 | 24 |
| K881116 | Diagnostic Systems | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | 1988-06-20 | 97 |
Recalls for KLR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-06-26.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code KLR?
KLR is the FDA product code for enzyme immunoassay, lidocaine. It is a Class II device, regulated under 21 CFR 862.3555 and reviewed by the Clinical Toxicology panel.
What device class is KLR?
Class II, regulation 21 CFR 862.3555. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLR?
Across 17 cleared submissions the average was 59 days from receipt to decision (median 55).
Which companies have the most KLR clearances?
Syva Co. (6); E.I. Dupont DE Nemours & Co., Inc. (2); Thermo Fisher Scientific, Inc. (1); Dade Behring, Inc. (1); Roche Diagnostics Corp. (1).
Have KLR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code KLR
- Run a recall and safety report across every KLR manufacturer
- Watch product code KLR 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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