RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR— 510(k) K123977
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K123977 for RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR, Substantially Equivalent on 2013-11-21. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
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