CPK REAGENT
FDA 510(k) clearance K112416 · decided 2011-11-09
Clearance details
- K-number
- K112416
- Device name
- CPK REAGENT
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
- Decision
- Substantially Equivalent
- Date received
- 2011-08-22
- Decision date
- 2011-11-09
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Noble Park, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.