RANDOX HUMAN ASSSAYED DRUG CONTROL— 510(k) K012319
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K012319 for RANDOX HUMAN ASSSAYED DRUG CONTROL, Substantially Equivalent on 2001-08-24. Applicant: Randox Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, Co. Antrim, GB
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More clearances from Randox Laboratories, Ltd.
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