FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
K Number: K082248
·
Decision Dec 12, 2008
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
16
Review Days
126
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Basic Information
- Device Name
- STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
- K Number
- K082248
- 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
- August 8, 2008
- Decision Date
- December 12, 2008
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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