Quest Diagnostics Methamphetamine Micro-Plate Eia
FDA 510(k) K080381 · Quest Diagnostics, Inc.
510(k) numberK080381
Submission
- Device name
- Quest Diagnostics Methamphetamine Micro-Plate Eia
- Applicant
- Quest Diagnostics, Inc.
Lenexa, KS, US - Received
- February 13, 2008
- Decision date
- June 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAF – Gas Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | Biophor Diagnostics, Inc. | 12/18/2014SE |
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLAF · Traditional | Lin-Zhi International, Inc. | 03/21/2014SE |
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| 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 Methamphetamine Micro-Plate Eia cleared by the FDA?
Quest Diagnostics Methamphetamine Micro-Plate Eia (K080381) received a 510(k) decision of Substantially Equivalent on June 25, 2008, 133 days after the submission was received.
What is the product code of K080381?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.