FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K Number: K883320
·
Decision Sep 27, 1988
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
191
Review Days
53
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Basic Information
- Device Name
- MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
- K Number
- K883320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- August 5, 1988
- Decision Date
- September 27, 1988
- 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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