METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)— 510(k) K031797
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K031797 for METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT), Substantially Equivalent on 2003-10-10. Applicant: Lin-Zhi International, Inc.. Device class: 2.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Synnyvale, CA, US
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