RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL— 510(k) K140522
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K140522 for RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL, Substantially Equivalent on 2014-05-22. Applicant: Randox Laboratories Limited.
Clearance details
- Applicant
- Randox Laboratories Limited
- Product code
- Code JJY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.