Drugcheck X Multidrug Screening Device
FDA 510(k) K992748 · Syntron Bioresearch, Inc.
510(k) numberK992748
Submission
- Device name
- Drugcheck X Multidrug Screening Device
- Applicant
- Syntron Bioresearch, Inc.
Simi Valley, CA, US - Received
- August 16, 1999
- Decision date
- September 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | Carolina Liquid Chemistries Corp. | 01/27/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 09/24/2021SE |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO · Traditional | Medtest DX | 03/12/2020SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 07/06/2018SE |
| K170293 | Emit II Plus Cocaine Metabolite AssayDIO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/25/2017SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | Carolina Liquid Chemistries Corporation | 08/15/2017SE |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO · Special | Mp Biomedicals, LLC | 06/02/2017SE |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | Quest Diagnostics Incorporated | 11/18/2016SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 06/27/2016SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 03/18/2016SE |
More from Safecare Biotech (Hangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K992990 | Quickpac II One Step Cocaine TestDIO · Traditional | 09/20/1999SE |
| K992207 | Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test SystemDIO · Traditional | 07/22/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | 06/24/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | 11/18/1998SE |
| K981292 | Quikpac II One Step Phencyclidine (PCP) TestLCM · Traditional | 05/26/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | 05/07/1998SE |
| K980349 | Quickpac II One Step Barbiturate TestDIS · Traditional | 03/03/1998SE |
| K974712 | Quikstrip One Step Barbiturate TestDIS · Traditional | 02/12/1998SE |
Questions and answers
When was Drugcheck X Multidrug Screening Device cleared by the FDA?
Drugcheck X Multidrug Screening Device (K992748) received a 510(k) decision of Substantially Equivalent on September 2, 1999, 17 days after the submission was received.
What is the product code of K992748?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.