S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
FDA 510(k) clearance K091413 · decided 2009-10-26
Clearance details
- K-number
- K091413
- Device name
- S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
- Applicant
- Alfa Wassermann, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-13
- Decision date
- 2009-10-26
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Caldwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.