Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls
FDA 510(k) K063024 · Lin-Zhi International, Inc.
510(k) numberK063024
Submission
- Device name
- Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls
- Applicant
- Lin-Zhi International, Inc.
Synnyvale, CA, US - Received
- October 2, 2006
- Decision date
- October 30, 2006
- 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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Questions and answers
When was Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls cleared by the FDA?
Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls (K063024) received a 510(k) decision of Substantially Equivalent on October 30, 2006, 28 days after the submission was received.
What is the product code of K063024?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.