TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
FDA 510(k) clearance K895664 · decided 1989-11-14
Clearance details
- K-number
- K895664
- Device name
- TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-20
- Decision date
- 1989-11-14
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.