FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
K Number: K093861
·
Decision Feb 5, 2010
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- K Number
- K093861
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iris International, Inc.
- Date Received
- December 16, 2009
- Decision Date
- February 5, 2010
- Product Code
- LKM
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKM | Counter, Urine Particle | FDA class 2 | Hematology |
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