FDA product code LAG: High Pressure Liquid Chromatography, Methamphetamine
LAG is the FDA product code for high pressure liquid chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under LAG, from 2 different applicants. The average 510(k) review took 188 days (median 142).
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Methamphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3610 |
| 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 LAG clearance
Top LAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Princeton BioMeditech Corp. | 3 | 2007-11-26 |
| American Bio Medica Corp. | 1 | 2008-05-30 |
Most recent LAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073078 | American Bio Medica Corp. | RAPID TOX CUP | 2008-05-30 | 212 |
| K062575 | Princeton BioMeditech Corp. | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | 2007-11-26 | 452 |
| K990786 | Princeton BioMeditech Corp. | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ | 1999-03-26 | 16 |
| K983501 | Princeton BioMeditech Corp. | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ | 1998-12-18 | 73 |
Recalls for LAG devices
openFDA lists no recalls for product code LAG.
Frequently asked questions
What is FDA product code LAG?
LAG is the FDA product code for high pressure liquid chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel.
What device class is LAG?
Class II, regulation 21 CFR 862.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAG?
Across 4 cleared submissions the average was 188 days from receipt to decision (median 142).
Which companies have the most LAG clearances?
Princeton BioMeditech Corp. (3); American Bio Medica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAG
- Run a recall and safety report across every LAG manufacturer
- Watch product code LAG 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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