Quest Diagnostics Haircheck-Dt (Amphetamines)
FDA 510(k) K051161 · Quest Diagnostics, Inc.
510(k) numberK051161
Submission
- Device name
- Quest Diagnostics Haircheck-Dt (Amphetamines)
- Applicant
- Quest Diagnostics, Inc.
Las Vegas, NV, US - Received
- May 5, 2005
- Decision date
- November 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | 11/18/2016SE |
| K080381 | Quest Diagnostics Methamphetamine Micro-Plate EiaLAF · Traditional | 06/25/2008SE |
| K062929 | Quest Diagnostics Urine Cocaine Metabolite EiaDIO · Traditional | 12/18/2006SE |
| 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 (Amphetamines) cleared by the FDA?
Quest Diagnostics Haircheck-Dt (Amphetamines) (K051161) received a 510(k) decision of Substantially Equivalent on November 22, 2005, 201 days after the submission was received.
What is the product code of K051161?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.