FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZEE FILTER/SEPARATOR
K Number: K831081
·
Decision May 16, 1983
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- EZEE FILTER/SEPARATOR
- K Number
- K831081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Kendall Company Div. of Tyco Healthcare Group
- Date Received
- April 4, 1983
- Decision Date
- May 16, 1983
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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