AIA-PACK T4
FDA 510(k) clearance K896982 · decided 1990-03-09
Clearance details
- K-number
- K896982
- Device name
- AIA-PACK T4
- Applicant
- Tosoh Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-19
- Decision date
- 1990-03-09
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.