SOPHEIA/MP CORTISOL EIA KIT
FDA 510(k) clearance K850008 · decided 1985-02-01
Clearance details
- K-number
- K850008
- Device name
- SOPHEIA/MP CORTISOL EIA KIT
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-02
- Decision date
- 1985-02-01
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CGR
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.