QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA— 510(k) K080381
Substantially EquivalentQuest Diagnostics, Inc.
FDA 510(k) clearance K080381 for QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA, Substantially Equivalent on 2008-06-25. Applicant: Quest Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Quest Diagnostics, Inc.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code LAF
view all- K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
- K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
- K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
- K170222 — Rapid Tox Cup II
- K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
More clearances from Quest Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.