Accusign Doa 10,ACCUSIGN Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/
FDA 510(k) K983501 · Princeton BioMeditech Corp.
510(k) numberK983501
Submission
- Device name
- Accusign Doa 10,ACCUSIGN Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/
- Applicant
- Princeton BioMeditech Corp.
Princeton, NJ, US - Received
- October 6, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K073078 | Rapid Tox CupLAG · Traditional | American Bio Medica Corp. | 05/30/2008SE |
| 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 |
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Questions and answers
When was Accusign Doa 10,ACCUSIGN Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/ cleared by the FDA?
Accusign Doa 10,ACCUSIGN Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/ (K983501) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 73 days after the submission was received.
What is the product code of K983501?
The FDA product code is LAG – High Pressure Liquid Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.