CHOLESTEROL DETERMINATION
FDA 510(k) clearance K871260 · decided 1987-04-13
Clearance details
- K-number
- K871260
- Device name
- CHOLESTEROL DETERMINATION
- Applicant
- Biochemical Trade, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-31
- Decision date
- 1987-04-13
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.