AUDIT MICROCV PROCALCITONIN LINEARITY
FDA 510(k) clearance K101434 · decided 2010-07-22
Clearance details
- K-number
- K101434
- Device name
- AUDIT MICROCV PROCALCITONIN LINEARITY
- Applicant
- Aalto Scientific, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-21
- Decision date
- 2010-07-22
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- MJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.