Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign Doa 8, Biosign Thc/Opi/Coc/Amp/P
FDA 510(k) K983147 · Princeton BioMeditech Corp.
510(k) numberK983147
Submission
- Device name
- Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign Doa 8, Biosign Thc/Opi/Coc/Amp/P
- Applicant
- Princeton BioMeditech Corp.
Princeton, NJ, US - Received
- September 8, 1998
- Decision date
- September 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKE – Reagents, Test, Tetrahydrocannabinol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003687 | Verdict II Thc/Coc/Opi/Amp, Verdictii Thc/Coc/Opi,Verdict II Thc/Coc/Amp,Verdict II…DKE · Special | Medtox Diagnostics, Inc. | 12/22/2000SE |
| K994405 | Instant-View Marijuana Urine Cassette TestDKE · Traditional | Alfa Scientific Designs, Inc. | 06/02/2000SE |
| K992068 | Status Stik, Accusign StikDKE · Special | Princeton BioMeditech Corp. | 07/06/1999SE |
| K991751 | Status Cup Accusign CupDKE · Special | Princeton BioMeditech Corp. | 06/18/1999SE |
| K991078 | Accusign DOA8, DOA8 Panel, Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign DOA8…DKE · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K982211 | Profile-Ii Model 600582DKE · Traditional | Medtox Diagnostics, Inc. | 07/29/1998SE |
| K901694 | Spec(Tm) Extraction CartridgeDKE · Traditional | Toxi-Lab, Inc. | 06/01/1990SE |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | Marion Laboratories, Inc. | 07/05/1988SE |
| K841831 | Cannu-Skreen-PreliminaryDKE · Traditional | Biochemical Diagnostic, Inc. | 07/06/1984SE |
| K831456 | Toxi-Lab Cannabinoid THC ScreenDKE · Traditional | Marion Laboratories, Inc. | 06/30/1983SE |
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| K133474 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 12/10/2013SE |
| K132465 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 09/09/2013SE |
| K083746 | Biosign Flu A+BPSZ · Traditional | 11/10/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | 07/01/2010SE |
| K100341 | Spermcheck FertilityPOV · Traditional | 05/04/2010SE |
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Questions and answers
When was Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign Doa 8, Biosign Thc/Opi/Coc/Amp/P cleared by the FDA?
Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign Doa 8, Biosign Thc/Opi/Coc/Amp/P (K983147) received a 510(k) decision of Substantially Equivalent on September 28, 1998, 20 days after the submission was received.
What is the product code of K983147?
The FDA product code is DKE – Reagents, Test, Tetrahydrocannabinol, a Class II (moderate risk) device regulated under 21 CFR 862.3870.