MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
FDA 510(k) clearance K012789 · decided 2002-01-17
Clearance details
- K-number
- K012789
- Device name
- MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
- Applicant
- Morax
- Decision
- Substantially Equivalent
- Date received
- 2001-08-20
- Decision date
- 2002-01-17
- Days to decision
- 150 days
- Clearance type
- Special
- Product code
- JHO
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chelsea, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.