HOME ACCESS AIC TEST
FDA 510(k) clearance K141944 · decided 2015-03-13
Clearance details
- K-number
- K141944
- Device name
- HOME ACCESS AIC TEST
- Applicant
- Home Access Health Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-17
- Decision date
- 2015-03-13
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.