FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K Number: K071934
·
Decision Oct 11, 2007
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
93
Review Days
90
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Basic Information
- Device Name
- MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
- K Number
- K071934
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Manufacturing Corp
- Date Received
- July 13, 2007
- Decision Date
- October 11, 2007
- 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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