RANDOX TRI LEVEL CARDIAC CONTROL— 510(k) K041361
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K041361 for RANDOX TRI LEVEL CARDIAC CONTROL, Substantially Equivalent on 2004-09-09. Applicant: Randox Laboratories Limited. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories Limited
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
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