CHOLESTECH BUN/CREATININE TEST SYSTEM— 510(k) K972012
Substantially EquivalentCholestech Corp.
FDA 510(k) clearance K972012 for CHOLESTECH BUN/CREATININE TEST SYSTEM, Substantially Equivalent on 1997-07-24. Applicant: Cholestech Corp.. Device class: 2.
Clearance details
- Applicant
- Cholestech Corp.
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
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More clearances from Cholestech Corp.
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