HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
FDA 510(k) clearance K111753 · decided 2011-12-14
Clearance details
- K-number
- K111753
- Device name
- HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-22
- Decision date
- 2011-12-14
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.