IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
FDA 510(k) clearance K823352 · decided 1983-02-07
Clearance details
- K-number
- K823352
- Device name
- IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1982-11-09
- Decision date
- 1983-02-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.