DIRECT LDL CHOLESTEROL, MODEL L530-60H
FDA 510(k) clearance K051121 · decided 2005-08-08
Clearance details
- K-number
- K051121
- Device name
- DIRECT LDL CHOLESTEROL, MODEL L530-60H
- Applicant
- Teco Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2005-05-02
- Decision date
- 2005-08-08
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.