FDA product code LAN: Enzyme Immunoassay, N-Acetylprocainamide
LAN is the FDA product code for enzyme immunoassay, n-acetylprocainamide. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 21 510(k) submissions under LAN, from 14 different applicants. The average 510(k) review took 51 days (median 35). FDA has posted 1 recall for LAN devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, N-Acetylprocainamide |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| 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 LAN clearance
Top LAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 5 | 1992-08-24 |
| Abbott Laboratories | 2 | 1996-04-24 |
| Roche Diagnostic Systems, Inc. | 2 | 1987-06-08 |
| American Dade | 2 | 1986-02-06 |
| Roche Diagnostics Corp. | 1 | 2006-08-16 |
9 more applicants have LAN clearances. See the full list in Caduvo.
Most recent LAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060738 | Roche Diagnostics Corp. | TDM N-ACETYLPROCAINAMIDE | 2006-08-16 | 149 |
| K032564 | Dade Behring, Inc. | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | 2003-10-31 | 72 |
| K011620 | Syva Co., Dade Behring, Inc. | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | 2001-06-18 | 24 |
| K983812 | Diagnostic Reagents, Inc. | NAPA EIA ASSAY | 1998-11-16 | 19 |
| K971713 | Bayer Corp. | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 1997-06-11 | 33 |
Recalls for LAN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-02-05.
Frequently asked questions
What is FDA product code LAN?
LAN is the FDA product code for enzyme immunoassay, n-acetylprocainamide. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is LAN?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAN?
Across 21 cleared submissions the average was 51 days from receipt to decision (median 35).
Which companies have the most LAN clearances?
Syva Co. (5); Abbott Laboratories (2); Roche Diagnostic Systems, Inc. (2); American Dade (2); Roche Diagnostics Corp. (1).
Have LAN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LAN
- Run a recall and safety report across every LAN manufacturer
- Watch product code LAN 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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