FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STA - CONTROL LA 1+2
K Number: K061803
·
Decision Jul 28, 2006
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
16
Review Days
31
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Basic Information
- Device Name
- STA - CONTROL LA 1+2
- K Number
- K061803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostica Stago, Inc.
- Date Received
- June 27, 2006
- Decision Date
- July 28, 2006
- Product Code
- GGC
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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