FDA product code KLB: Radioimmunoassay, Tobramycin
KLB is the FDA product code for radioimmunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. FDA has cleared 23 510(k) submissions under KLB, from 17 different applicants. The average 510(k) review took 46 days (median 29). FDA has posted 2 recalls for KLB devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Tobramycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3900 |
| 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 KLB clearance
Top KLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 3 | 2001-08-20 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 1990-10-26 |
| Syva Co. | 2 | 1988-07-01 |
| Bio-Rad | 2 | 1979-10-17 |
| Roche Diagnostics Corp. | 1 | 2006-06-09 |
12 more applicants have KLB clearances. See the full list in Caduvo.
Most recent KLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060853 | Roche Diagnostics Corp. | ONLINE TDM TOBRAMYCIN | 2006-06-09 | 72 |
| K012312 | Diagnostic Products Corp. | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) | 2001-08-20 | 28 |
| K003341 | Syva Co., Dade Behring, Inc. | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | 2001-01-22 | 89 |
| K904304 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD | 1990-10-26 | 37 |
| K903192 | Instrumentation Laboratory CO | IL TOBRAMYCIN ASSAY | 1990-08-22 | 34 |
Recalls for KLB devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-04-05.
Frequently asked questions
What is FDA product code KLB?
KLB is the FDA product code for radioimmunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is KLB?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLB?
Across 23 cleared submissions the average was 46 days from receipt to decision (median 29).
Which companies have the most KLB clearances?
Diagnostic Products Corp. (3); E.I. Dupont DE Nemours & Co., Inc. (3); Syva Co. (2); Bio-Rad (2); Roche Diagnostics Corp. (1).
Have KLB devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2007-04-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KLB
- Run a recall and safety report across every KLB manufacturer
- Watch product code KLB 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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