FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K Number: K081345
·
Decision Jul 10, 2008
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
3
Review Days
57
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Basic Information
- Device Name
- AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
- K Number
- K081345
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Thermogenesis Corp.
- Date Received
- May 14, 2008
- Decision Date
- July 10, 2008
- Product Code
- JQC
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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