LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS— 510(k) K063024
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K063024 for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS, Substantially Equivalent on 2006-10-30. Applicant: Lin-Zhi International, Inc.. Device class: 2.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Synnyvale, CA, US
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