CHOLESTEROL REGEANT SET
FDA 510(k) clearance K914160 · decided 1992-01-30
Clearance details
- K-number
- K914160
- Device name
- CHOLESTEROL REGEANT SET
- Applicant
- Tech Intl. Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-17
- Decision date
- 1992-01-30
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester Hills, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.