FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K Number: K002885
·
Decision Jun 21, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
37
Applicant Total
343
Review Days
279
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Basic Information
- Device Name
- DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
- K Number
- K002885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- September 15, 2000
- Decision Date
- June 21, 2001
- Product Code
- JOZ
- 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 |
|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | FDA class 2 | Hematology |
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