GENCHEM ISE ELECTROLYTE REFERENCE
FDA 510(k) clearance K040971 · decided 2004-12-22
Clearance details
- K-number
- K040971
- Device name
- GENCHEM ISE ELECTROLYTE REFERENCE
- Applicant
- Genchem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-14
- Decision date
- 2004-12-22
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.