RANDOX MYOGLOBIN— 510(k) K010700
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K010700 for RANDOX MYOGLOBIN, Substantially Equivalent on 2001-05-08. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, Co. Antrim, IE
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More clearances from Randox Laboratories, Ltd.
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