CLEARBLUE EASY
FDA 510(k) clearance K905742 · decided 1991-02-13
Clearance details
- K-number
- K905742
- Device name
- CLEARBLUE EASY
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-24
- Decision date
- 1991-02-13
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford Mk41 Oqg, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.