FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K Number: K030555
·
Decision Apr 11, 2003
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
441
Review Days
49
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Basic Information
- Device Name
- GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
- K Number
- K030555
- 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, Inc.
- Date Received
- February 21, 2003
- Decision Date
- April 11, 2003
- 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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