Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers— 510(k) K201442
Substantially EquivalentDiatron Group
FDA 510(k) clearance K201442 for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers, Substantially Equivalent on 2020-07-31. Applicant: Diatron Group. Device class: 2.
Clearance details
- Applicant
- Diatron Group
- 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
- Medley, FL, US
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More clearances from Diatron Group
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