LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
FDA 510(k) clearance K871187 · decided 1987-05-28
Clearance details
- K-number
- K871187
- Device name
- LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
- Applicant
- In Vitro Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-24
- Decision date
- 1987-05-28
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JIS
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.