VITRO T4-EIA-XT
FDA 510(k) clearance K896865 · decided 1990-01-30
Clearance details
- K-number
- K896865
- Device name
- VITRO T4-EIA-XT
- Applicant
- In Vitro Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-06
- Decision date
- 1990-01-30
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.