CALIBRATION SERUM LEVEL 1 & 2— 510(k) K955489
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K955489 for CALIBRATION SERUM LEVEL 1 & 2, Substantially Equivalent on 1996-06-21. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, IE
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