PROLYTE ELECTROLYTE ANALYZER
FDA 510(k) clearance K070104 · decided 2008-05-07
Clearance details
- K-number
- K070104
- Device name
- PROLYTE ELECTROLYTE ANALYZER
- Applicant
- Diamond Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-10
- Decision date
- 2008-05-07
- Days to decision
- 483 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Holliston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.