High Pressure Liquid Chromatography, Methamphetamine
High pressure liquid chromatography for methamphetamine testing is a laboratory instrument method used to detect and quantify methamphetamine in biological samples for toxicological or drug monitoring purposes. FDA Class 2 classification is assigned, necessitating 510(k) premarket clearance. The product code is LAG, regulated under 21 CFR 862.3610, in the Clinical Toxicology specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- LAG
- Device Class
- FDA class 2
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073078 | RAPID TOX CUP | May 30, 2008 | Substantially Equivalent | American Bio Medica Corp. |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Nov 26, 2007 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ | Mar 26, 1999 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ | Dec 18, 1998 | Substantially Equivalent | Princeton BioMeditech Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.