CLINALYZER MODEL VX-1000
FDA 510(k) clearance K851638 · decided 1985-05-13
Clearance details
- K-number
- K851638
- Device name
- CLINALYZER MODEL VX-1000
- Applicant
- Alpkem Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-19
- Decision date
- 1985-05-13
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.