CHOLESTEROL TEST SYSTEM
FDA 510(k) clearance K850390 · decided 1985-07-09
Clearance details
- K-number
- K850390
- Device name
- CHOLESTEROL TEST SYSTEM
- Applicant
- Hans J. Brouwers & Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-01
- Decision date
- 1985-07-09
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mount Prospect, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.