CHOLESTECH L.D.X. SYSTEM
FDA 510(k) clearance K932727 · decided 1993-11-09
Clearance details
- K-number
- K932727
- Device name
- CHOLESTECH L.D.X. SYSTEM
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-04
- Decision date
- 1993-11-09
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.