CHOLESTECH BUN/CREATININE TEST SYSTEM
FDA 510(k) clearance K972012 · decided 1997-07-24
Clearance details
- K-number
- K972012
- Device name
- CHOLESTECH BUN/CREATININE TEST SYSTEM
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-30
- Decision date
- 1997-07-24
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- CDN
- Device class
- 2
- Regulation number
- 862.1770
- 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.