IQ 200 SYSTEM
FDA 510(k) clearance K022774 · decided 2002-10-21
Clearance details
- K-number
- K022774
- Device name
- IQ 200 SYSTEM
- Applicant
- Intl. Remote Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-08-21
- Decision date
- 2002-10-21
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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