OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS— 510(k) K050988
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K050988 for OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS, Substantially Equivalent on 2006-04-06. Applicant: Lin-Zhi International, Inc.. Device class: 1.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code DLG
- Device class
- Class 1
- Regulation
- 21 CFR 862.2250
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Synnyvale, CA, US
Recent devices under product code DLG
view allMore clearances from Lin-Zhi International, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.