Cholesterol
FDA 510(k) clearance K150654 · decided 2015-09-29
Clearance details
- K-number
- K150654
- Device name
- Cholesterol
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-13
- Decision date
- 2015-09-29
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.