CONCEP-7-BHCG (EIA)
FDA 510(k) clearance K844153 · decided 1984-12-14
Clearance details
- K-number
- K844153
- Device name
- CONCEP-7-BHCG (EIA)
- Applicant
- Leeco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-24
- Decision date
- 1984-12-14
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Southfield, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.