PARAMAX COMPREHENSIVE CALIBRATOR
FDA 510(k) clearance K855199 · decided 1986-02-19
Clearance details
- K-number
- K855199
- Device name
- PARAMAX COMPREHENSIVE CALIBRATOR
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1985-12-27
- Decision date
- 1986-02-19
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.