LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
FDA 510(k) clearance K970778 · decided 1997-04-17
Clearance details
- K-number
- K970778
- Device name
- LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
- Applicant
- More Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1997-03-04
- Decision date
- 1997-04-17
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Osos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.