IMMOCARE
FDA 510(k) clearance K052598 · decided 2006-03-16
Clearance details
- K-number
- K052598
- Device name
- IMMOCARE
- Applicant
- Care Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-21
- Decision date
- 2006-03-16
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Klamath Falls, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.