Rapid Tox Cup
FDA 510(k) K073078 · American Bio Medica Corp.
510(k) numberK073078
Submission
- Device name
- Rapid Tox Cup
- Applicant
- American Bio Medica Corp.
Logan Township, NJ, US - Received
- October 31, 2007
- Decision date
- May 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAG – High Pressure Liquid Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/AmpLAG · Traditional | Princeton BioMeditech Corp. | 11/26/2007SE |
| K990786 | Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp…LAG · Special | Princeton BioMeditech Corp. | 03/26/1999SE |
| K983501 | Accusign Doa 10,ACCUSIGN Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp,Biosi…LAG · Traditional | Princeton BioMeditech Corp. | 12/18/1998SE |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
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| K170222 | Rapid Tox Cup IILAF · Traditional | 08/15/2017SE |
| K060760 | Rapidone-Buprenorphine TestDJG · Traditional | 08/07/2006SE |
| K053422 | RAPIDONE-COCAINE-150 TestDIO · Traditional | 06/15/2006SE |
| K053359 | RapidtoxDKZ · Special | 05/25/2006SE |
| K041696 | Rapid ReaderDKZ · Traditional | 07/12/2005SE |
| K041712 | 'Rapidtec 4' TestDIS · Traditional | 11/03/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | 04/30/2003SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | 07/23/2002SE |
| K014101 | Rapidone-Oxy TestDJG · Traditional | 03/20/2002SE |
Questions and answers
When was Rapid Tox Cup cleared by the FDA?
Rapid Tox Cup (K073078) received a 510(k) decision of Substantially Equivalent on May 30, 2008, 212 days after the submission was received.
What is the product code of K073078?
The FDA product code is LAG – High Pressure Liquid Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.