CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
FDA 510(k) clearance K950589 · decided 1995-03-20
Clearance details
- K-number
- K950589
- Device name
- CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
- Applicant
- Creative Laboratory Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-09
- Decision date
- 1995-03-20
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.