ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
FDA 510(k) clearance K930796 · decided 1994-01-13
Clearance details
- K-number
- K930796
- Device name
- ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
- Applicant
- Alko Diagnostic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-16
- Decision date
- 1994-01-13
- Days to decision
- 331 days
- Clearance type
- Traditional
- Product code
- JZX
- Device class
- 1
- Regulation number
- 866.4830
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.