Product code LAG
- Device name
- High Pressure Liquid Chromatography, Methamphetamine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3610
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073078 | RAPID TOX CUP | American Bio Medica Corp. | 2008-05-30 |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Princeton BioMeditech Corp. | 2007-11-26 |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ | Princeton BioMeditech Corp. | 1999-03-26 |
| 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/ | Princeton BioMeditech Corp. | 1998-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10694644200161 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200307 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200291 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200284 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200277 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200260 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200253 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200246 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200239 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200222 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200215 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200208 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200192 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200185 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200178 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200017 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200154 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200147 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200130 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200123 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200116 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200109 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200093 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200086 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200079 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200062 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200055 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200048 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200031 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200024 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |