DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
FDA 510(k) clearance K072523 · decided 2008-01-22
Clearance details
- K-number
- K072523
- Device name
- DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- Applicant
- General Atomics
- Decision
- Substantially Equivalent
- Date received
- 2007-09-07
- Decision date
- 2008-01-22
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- LBR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.