PARAMAX CHOLESTEROL REAGENT
FDA 510(k) clearance K872050 · decided 1987-07-07
Clearance details
- K-number
- K872050
- Device name
- PARAMAX CHOLESTEROL REAGENT
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1987-05-28
- Decision date
- 1987-07-07
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- LBS
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.