OVEIA (TM) DUAL ANALYTE
FDA 510(k) clearance K872843 · decided 1988-02-02
Clearance details
- K-number
- K872843
- Device name
- OVEIA (TM) DUAL ANALYTE
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-20
- Decision date
- 1988-02-02
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- JLP
- Device class
- 1
- Regulation number
- 862.1605
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Berkshire, England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.