KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
FDA 510(k) clearance K070183 · decided 2007-07-13
Clearance details
- K-number
- K070183
- Device name
- KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-19
- Decision date
- 2007-07-13
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- OCN
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Boise, ID, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.