MODIFICATION TO E.P.T. PREGNANCY TEST
FDA 510(k) clearance K040329 · decided 2004-03-08
Clearance details
- K-number
- K040329
- Device name
- MODIFICATION TO E.P.T. PREGNANCY TEST
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-11
- Decision date
- 2004-03-08
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.