3M INTEGRATED CYCLER (110V) & (220V)
FDA 510(k) clearance K102314 · decided 2010-10-29
Clearance details
- K-number
- K102314
- Device name
- 3M INTEGRATED CYCLER (110V) & (220V)
- Applicant
- Focus Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-16
- Decision date
- 2010-10-29
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- OOI
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.