FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
K Number: K021927
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
303
Registration Numbers
304
Same Product Code
2
Applicant Total
441
Review Days
30
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Basic Information
- Device Name
- PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
- K Number
- K021927
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- June 12, 2002
- Decision Date
- July 12, 2002
- Product Code
- LXG
- 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 |
|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXG), ordered by most recent decision date.
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