FDA product code LCR: Fluorescent Immunoassay, Tobramycin
LCR is the FDA product code for fluorescent immunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. FDA has cleared 17 510(k) submissions under LCR, from 17 different applicants. The average 510(k) review took 45 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent Immunoassay, 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 LCR clearance
Top LCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Seradyn, Inc. | 1 | 2006-07-21 |
| Chiron Diagnostics Corp. | 1 | 1998-02-12 |
| Dade Intl., Inc. | 1 | 1996-09-13 |
| Beckman Instruments, Inc. | 1 | 1995-08-08 |
| Pb Diagnostic Systems, Inc. | 1 | 1991-07-01 |
12 more applicants have LCR clearances. See the full list in Caduvo.
Most recent LCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060998 | Seradyn, Inc. | QMS TOBRAMYCIN | 2006-07-21 | 101 |
| K974029 | Chiron Diagnostics Corp. | ACS TOBRAMYCIN | 1998-02-12 | 112 |
| K962818 | Dade Intl., Inc. | TOBRAMYCIN FLEX REAGENT CARTRIDGE | 1996-09-13 | 56 |
| K952568 | Beckman Instruments, Inc. | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | 1995-08-08 | 64 |
| K911940 | Pb Diagnostic Systems, Inc. | OPUS(R) TOBRAMYCIN | 1991-07-01 | 61 |
Recalls for LCR devices
openFDA lists no recalls for product code LCR.
Frequently asked questions
What is FDA product code LCR?
LCR is the FDA product code for fluorescent immunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is LCR?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCR?
Across 17 cleared submissions the average was 45 days from receipt to decision (median 36).
Which companies have the most LCR clearances?
Seradyn, Inc. (1); Chiron Diagnostics Corp. (1); Dade Intl., Inc. (1); Beckman Instruments, Inc. (1); Pb Diagnostic Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCR
- Run a recall and safety report across every LCR manufacturer
- Watch product code LCR 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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