MAGNETIC HDL CHOLESTEROL TEST
FDA 510(k) clearance K944975 · decided 1995-08-02
Clearance details
- K-number
- K944975
- Device name
- MAGNETIC HDL CHOLESTEROL TEST
- Applicant
- Reference Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-11
- Decision date
- 1995-08-02
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- LBR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.