Quest Diagnostics HairCheck-DT (Cocaine)
FDA 510(k) K152232 · Quest Diagnostics Incorporated
510(k) numberK152232
Submission
- Device name
- Quest Diagnostics HairCheck-DT (Cocaine)
- Applicant
- Quest Diagnostics Incorporated
Lenexa, KS, US - Received
- August 7, 2015
- Decision date
- November 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…DIO · Traditional | Biophor Diagnostics, Inc. | 07/24/2015SE |
More from Biophor Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080381 | Quest Diagnostics Methamphetamine Micro-Plate EiaLAF · Traditional | 06/25/2008SE |
| K062929 | Quest Diagnostics Urine Cocaine Metabolite EiaDIO · Traditional | 12/18/2006SE |
| K051161 | Quest Diagnostics Haircheck-Dt (Amphetamines)DKZ · Traditional | 11/22/2005SE |
| K042726 | Quest Diagnostics Haircheck-Dt (PCPLCM · Traditional | 07/28/2005SE |
| K042725 | Quest Diagnostics Haircheck-Dt (Opiates)DJG · Traditional | 07/06/2005SE |
| K040257 | Quest Diagnostics Haircheck-Dt (THC)LDJ · Traditional | 06/14/2004SE |
| K023626 | Aml Haircheck-Dt (Cocaine)DIO · Traditional | 09/29/2003SE |
Questions and answers
When was Quest Diagnostics HairCheck-DT (Cocaine) cleared by the FDA?
Quest Diagnostics HairCheck-DT (Cocaine) (K152232) received a 510(k) decision of Substantially Equivalent on November 18, 2016, 469 days after the submission was received.
What is the product code of K152232?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.